FDA Product Code
FDA Product Code MAX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3080
510(k) Clearances — 896 records · page 5 of 9
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K170553 | Altus Spine Interbody Fusion System | Altus Partners, LLC | 2017-12-01 | Traditional | PDF ↗ |
| K172020 | Arlington PLIF/TLIF Cage | Signature Orthopaedics Pty, Ltd. | 2017-11-29 | Traditional | PDF ↗ |
| K170235 | Lucent® | Spinal Elements, Inc. | 2017-11-29 | Traditional | PDF ↗ |
| K163595 | IMPIX 3D Print Cages | Medicrea International SA | 2017-11-13 | Traditional | PDF ↗ |
| K172392 | Lateral Spinal Truss System (LSTS) Interbody Fusion Device | 4Web, Inc. | 2017-11-07 | Traditional | PDF ↗ |
| K170341 | Medussa-PL Cage | Medyssey USA, Inc. | 2017-11-02 | Traditional | PDF ↗ |
| K173080 | IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF) | Huvexel Co. , Ltd. | 2017-10-31 | Special | PDF ↗ |
| K172341 | NuVasive® Modulus TLIF Interbody System | Nu Vasive, Incorporated | 2017-10-26 | Traditional | PDF ↗ |
| K173022 | SeaSpine Ventura NanoMetalene System | SeaSpine Orthopedics Corporation | 2017-10-26 | Special | PDF ↗ |
| K172334 | Ortus Expandable Lumbar Interbody Fusion System | Atlas Spine, Inc. | 2017-10-25 | Traditional | PDF ↗ |
| K171914 | Cortina Lumbar Cage System | Neurostructures, Inc. | 2017-10-25 | Traditional | PDF ↗ |
| K172343 | Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology | Rti Surgical, Inc. | 2017-10-23 | Traditional | PDF ↗ |
| K172123 | NuVasive® Modulus XLIF Interbody System | Nu Vasive, Incorporated | 2017-10-11 | Traditional | PDF ↗ |
| K171689 | ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology | Medtronic Sofamor Danek USA, Inc. | 2017-10-05 | Traditional | PDF ↗ |
| K170119 | Calix Lumbar Spinal Implant System | X-Spine Systems, Inc. | 2017-09-29 | Traditional | PDF ↗ |
| K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | 2017-09-28 | Traditional | PDF ↗ |
| K171107 | CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System | Medtronic Sofamor Danek USA, Inc. | 2017-09-26 | Traditional | PDF ↗ |
| K172199 | ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium | Medtronic Sofamor Danek | 2017-09-19 | Traditional | PDF ↗ |
| K171519 | FLXfit | Expanding Orthopedics, Inc. | 2017-09-15 | Traditional | PDF ↗ |
| K172064 | Ti-Diagon Oblique TLIF | Camber Spine Technologies | 2017-09-15 | Traditional | PDF ↗ |
| K171351 | Posterior Spine Truss System (PSTS) Interbody Fusion Device | 4Web, Inc. | 2017-09-08 | Traditional | PDF ↗ |
| K171893 | Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone Synergy Cervical Interbody Fusion System (Slate) | Bluestone Synergy | 2017-09-08 | Traditional | PDF ↗ |
| K171329 | Altus Spine Titanium Interbody Fusion System | Altus Partners, LLC | 2017-08-29 | Special | PDF ↗ |
| K171660 | Duo Lumbar Interbody Fusion Device | Spineology, Inc. | 2017-08-18 | Special | PDF ↗ |
| K171657 | ShurFit 2C Lumbar Interbody Fusion System | Precision Spine, Inc. | 2017-08-11 | Traditional | PDF ↗ |
| K170888 | Renovis S141 Lumbar Interbody Fusion System | Renovis Surgical Technologies | 2017-08-08 | Traditional | PDF ↗ |
| K170851 | Anterior Spine Truss System (STS) Interbody Fusion Device | 4Web, Inc. | 2017-08-07 | Traditional | PDF ↗ |
| K170919 | The TiBow Expandable Spacer System | Life Spine, Inc. | 2017-08-03 | Traditional | PDF ↗ |
| K171630 | LumFuse-TP | Precifit Medical, Ltd. | 2017-07-25 | Traditional | PDF ↗ |
| K171724 | Rampart L Lumbar Interbody Fusion Device | Spineology, Inc. | 2017-07-24 | Special | PDF ↗ |
| K171425 | CONCORDE LIFT | Medos International SARL | 2017-07-20 | Traditional | PDF ↗ |
| K170676 | HD Lumbar Interbody System | Hd Lifesciences, LLC | 2017-07-13 | Traditional | PDF ↗ |
| K171656 | Genesys Spine Apache Interbody Fusion System | Genesys Spine | 2017-07-13 | Special | PDF ↗ |
| K170503 | EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages | Eit Emerging Implant Technologies GmbH | 2017-07-11 | Traditional | PDF ↗ |
| K171031 | CRESCENT Spinal System | Medtronic Sofamor Danek | 2017-07-06 | Special | PDF ↗ |
| K170399 | Endoskeleton TO Interbody Fusion Device (IBD) | Titan Spine, LLC | 2017-07-06 | Traditional | PDF ↗ |
| K161710 | SAGICO IBF SYSTEM ARIA LUMBAR, SAGICO IBF SYSTEM ARION CERVICAL | Spinal Analytics & Geometrical Impant Co, LLC | 2017-06-29 | Traditional | PDF ↗ |
| K170297 | Tranquil Interbody System | Nexus Spine, LLC | 2017-06-27 | Traditional | PDF ↗ |
| K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017-06-26 | Traditional | PDF ↗ |
| K163506 | Coalesce (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System | Vertera, Inc. | 2017-06-19 | Traditional | PDF ↗ |
| K171468 | FUSE Spinal System | Medtronic Sofamor Danek | 2017-06-13 | Special | PDF ↗ |
| K162986 | SPIRA Open Matrix ALIF | Camber Spine Technologies | 2017-06-12 | Traditional | PDF ↗ |
| K170395 | Talos® Lumbar (HA) PEEK IBF Devices | Meditech Spine, LLC | 2017-06-02 | Traditional | PDF ↗ |
| K170890 | TELIX K Interbody System | Biedermann Motech GmbH & Co. KG | 2017-06-02 | Traditional | PDF ↗ |
| K162212 | DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2017-05-19 | Traditional | PDF ↗ |
| K171097 | MOJAVE Expandable Interbody System | K2m, Inc. | 2017-05-10 | Special | PDF ↗ |
| K163481 | HALF DOME Posterior Lumbar Interbody System | Astura Medical | 2017-05-03 | Traditional | PDF ↗ |
| K163707 | NuVasive CoRoent Ti-C System | Nu Vasive, Incorporated | 2017-05-01 | Traditional | PDF ↗ |
| K170572 | Summit Spine Yellowstone Lumbar Interbody Fusion System | Summit Spine | 2017-04-26 | Traditional | PDF ↗ |
| K170511 | NeoFuse HA Enhanced PLIF/TLIF | Ht Medical, LLC | 2017-04-25 | Special | PDF ↗ |
| K170643 | Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System | Rti Surgical, Inc. Dba Rti Biologics | 2017-04-14 | Traditional | PDF ↗ |
| K163386 | Keos Lumbar IBFD | Keos | 2017-04-10 | Traditional | PDF ↗ |
| K163246 | Leva Anterior Expandable Spacer System | Spine Wave, Inc. | 2017-04-06 | Traditional | PDF ↗ |
| K162206 | Zavation IBF | Zavation, LLC | 2017-04-04 | Traditional | PDF ↗ |
| K170243 | LOSPA IS TLIF & DLIF Cages | Corentec Co., Ltd. | 2017-03-31 | Special | PDF ↗ |
| K162693 | VertebraLINK Fusion Platform | Facetlink Dba Linkspine | 2017-03-29 | Traditional | PDF ↗ |
| K163230 | NuVasive Modulus XLIF Interbody System | Nu Vasive, Incorporated | 2017-03-16 | Traditional | PDF ↗ |
| K163364 | MOJAVE Expandable Interbody System | K2m | 2017-03-15 | Traditional | PDF ↗ |
| K170512 | Altus Spine Titanium Interbody Fusion System | Altus Partners, LLC | 2017-03-10 | Special | PDF ↗ |
| K163409 | Rampart(TM) T Lumbar Interbody Fusion Device | Spineology, Inc. | 2017-03-08 | Traditional | PDF ↗ |
| K152022 | SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION® Spacers, COALITION AGX Spacers, INDEPENDENCE® Spacers, FORTIFY®-R Corpectomy Spacers, FORTIFY® I-R Corpectomy Spacers, XPand®-R Corpectomy Spacers, NIKO® Corpectomy Spacers, MONUMENT Spacers, ALTERA Spacers, MAGNIFY Spacers, InterContinental® Plate-Spacer | Globus Medical, Inc. | 2017-02-22 | Traditional | PDF ↗ |
| K162918 | Atlas Spine Expandable Interbody System | Atlas Spine, Inc. | 2017-02-09 | Traditional | PDF ↗ |
| K162879 | Elite Expandable Interbody Fusion Device | Spineology, Inc. | 2017-01-30 | Traditional | PDF ↗ |
| K160976 | Altus Spine Interbody Fusion System | Altus Partners, LLC | 2017-01-25 | Traditional | PDF ↗ |
| K163180 | Hubble II | Orbbo Surgical, LLC | 2016-12-29 | Traditional | PDF ↗ |
| K162446 | FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion System | Orthofix, Inc. | 2016-12-22 | Traditional | PDF ↗ |
| K162327 | COUGAR® LS Lateral Cage System and COUGAR® System | Medos International SARL | 2016-12-12 | Traditional | PDF ↗ |
| K162103 | Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine Interbody Fusion System (Harrier), Choice Spine Vertebral Body Replacement System (Hawkeye) | Choicespine, LP | 2016-11-23 | Traditional | PDF ↗ |
| K162431 | Luna 3D Interbody Fusion System | Benvenue Medical, Inc. | 2016-11-17 | Traditional | PDF ↗ |
| K160959 | Xsert Lumbar Expandable Interbody System | X-Spine Systems, Inc. | 2016-11-17 | Traditional | PDF ↗ |
| K160663 | Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF) | Evolution Spine, LLC | 2016-11-16 | Traditional | PDF ↗ |
| K162262 | Tritanium® PL Cage | Stryker | 2016-11-09 | Traditional | PDF ↗ |
| K160924 | Amendia Interbody Fusion Devices | Amendia, Inc. | 2016-11-08 | Traditional | PDF ↗ |
| K161438 | Genesys Spine Apache® Anterior Lumbar Interbody Fusion System | Genesys Spine | 2016-11-08 | Traditional | PDF ↗ |
| K162358 | T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System | Synthes USA Products, LLC | 2016-11-01 | Traditional | PDF ↗ |
| K162715 | SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene; SeaSpine Cambria NanoMetalene | SeaSpine Orthopedics Corporation | 2016-10-28 | Special | PDF ↗ |
| K160074 | Rampart D Lumbar Interbody Fusion Device | Spineology, Inc. | 2016-10-18 | Traditional | PDF ↗ |
| K160076 | XCage Interbody Fusion System | Ouroboros Medical, Inc. | 2016-10-13 | Traditional | PDF ↗ |
| K162426 | nva, nvp, and nvt | Nvision Biomedical Technologies, LLC | 2016-09-29 | Special | PDF ↗ |
| K162264 | Cascadia Interbody System | K2m, Inc. | 2016-09-21 | Special | PDF ↗ |
| K153665 | PROW FUSION-L | Nlt Spine, Ltd. | 2016-09-15 | Traditional | PDF ↗ |
| K161888 | JULIET® LL Lateral Lumbar Cage | Spineart | 2016-09-12 | Special | PDF ↗ |
| K161485 | Nanovis Intervertebral Body Fusion System and Forticore(R) | Nanovis, LLC | 2016-09-06 | Traditional | PDF ↗ |
| K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016-08-25 | Traditional | PDF ↗ |
| K160646 | XYcor® Expandable Spinal Spacer System | Alphatec Spine, Inc. | 2016-08-24 | Traditional | PDF ↗ |
| K161405 | Valeo II Interbody Fusion Device System | Amedica Corp. | 2016-08-19 | Special | PDF ↗ |
| K160856 | SpineView X-Pac Expandable Lumbar Cage System | Spine View, Inc. | 2016-08-01 | Traditional | PDF ↗ |
| K160699 | VIRTU Lumbar Spacer System | Met 1 Technologies, LLC | 2016-08-01 | Traditional | PDF ↗ |
| K161404 | Genesys Spine Apache® Lateral Lumbar Interbody Fusion System | Genesys Spine | 2016-07-21 | Special | PDF ↗ |
| K160955 | Tritanium® PL Cage | Stryker | 2016-07-21 | Traditional | PDF ↗ |
| K160631 | Keos Lumbar IBFD | Keos | 2016-07-15 | Traditional | PDF ↗ |
| K153621 | Juliet® Ti | Spineart | 2016-07-15 | Traditional | PDF ↗ |
| K160906 | Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device, Rampart A lumbar Interbody Fusion Device | Spineology, Inc. | 2016-07-14 | Traditional | PDF ↗ |
| K153105 | MLX - Medial Lateral Expandable Lumbar Interbody System | Nu Vasive, Incorporated | 2016-07-11 | Traditional | PDF ↗ |
| K153786 | PROW FUSION-V | Nlt Spine, Ltd. | 2016-07-11 | Traditional | PDF ↗ |
| K160715 | AccuLIF TL and PL Cage | Stryker Corporation | 2016-07-08 | Traditional | PDF ↗ |
| K152501 | Spinal Jaxx Interbody Fusion Device | Neuropro Spinaljaxx, Inc. | 2016-06-29 | Traditional | PDF ↗ |
| K160916 | CoRoent® Ti-C System | Nu Vasive, Incorporated | 2016-06-28 | Traditional | PDF ↗ |
| K160874 | Nanovis Intervertebral Body Fusion System and FortiCore® | Nanovis, LLC | 2016-06-28 | Special | PDF ↗ |
| K152011 | Lucent Intervertebral Body Fusion Device | Spinal Elements, Inc. | 2016-06-09 | Traditional | PDF ↗ |
Product code MAX · Class II · Orthopedic. Data: openFDA.