Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 31
- Latest Decision
- 2018-09-13
Clearances · page 39 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K181821 | MOSS VRS Spinal System | Biedermann Motech GmbH & Co. KG | NKB | Class II | 2018-09-13 |
| K181255 | PRODENSE Bone Graft Substitute | Wrightmedicaltechnologyinc | MQV | Class II | 2018-09-12 |
| K173424 | BioSphere Flex | Synergy Biomedical | MQV | Class II | 2018-09-12 |
| K181655 | Renovis S180 Lateral Lumbar Interbody Fusion System | Renovis Surgical Technologies | MAX | Class II | 2018-09-11 |
| K181380 | LnK Lumbar Interbody Fusion Cage System | L&K BIOMED Co., Ltd. | MAX | Class II | 2018-09-11 |
| K182055 | SECULOK ACP System | U&I Corporation | KWQ | Class II | 2018-09-10 |
| K182148 | SILVERBACK Gorilla Plating System | Paragon 28, Inc. | HWC | Class II | 2018-09-07 |
| K181061 | Corin Optimized Positioning System (OPS) Femoral | Corin USA | LZO | Class II | 2018-09-07 |
| K173883 | External Fixation System | Life Spine, Inc. | KTT | Class II | 2018-09-07 |
| K180728 | Spinal Elements Cerclage System | Spinal Elements, Inc. | OWI | Class II | 2018-09-06 |
| K173893 | Trabis | Coligne AG | PLR | Class II | 2018-09-06 |
| K181532 | Exactech Alteon Monobloc Revision Stem | Exactech, Inc. | LZO | Class II | 2018-09-04 |
| K182107 | CarriGen PF | Etex Corporation | MQV | Class II | 2018-08-31 |
| K181543 | Cure OPEL-C Plate System | Meditech Spine, LLC | KWQ | Class II | 2018-08-31 |
| K181225 | ALTAPORE | Baxter Healthcare Corporation | MQV | Class II | 2018-08-31 |
| K181228 | IlluminOss Bone Stabilization System | Illuminoss Medical, Inc. | QAD | Class II | 2018-08-31 |
| K181513 | Arthrex PushLock Tenodesis Anchor | Arthrex, Inc. | MBI | Class II | 2018-08-30 |
| K181262 | SpineJack Expansion Kit | Vexim SA | NDN | Class II | 2018-08-30 |
| K173380 | b-ONE® Total Hip System | B-One Ortho, Corp. | LZO | Class II | 2018-08-30 |
| K181471 | ACCUFUSE Cervical System | Absolute Advantage Medical, LLC | ODP | Class II | 2018-08-29 |
| K182119 | CD HORIZON Spinal System | Medtronic Sofamor Danek USA, Inc. | NKB | Class II | 2018-08-29 |
| K181799 | ResCUBE Ligament Fixation System | Cousin Biotech Sas | OWI | Class II | 2018-08-29 |
| K172906 | REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement | Osteoremedies, LLC | KWL | Class II | 2018-08-29 |
| K181295 | Genesys Spine AIS-C Cervical Stand-Alone System | Genesys Spine | OVE | Class II | 2018-08-29 |
| K181483 | Tranquil Interbody System | Nexus Spine, LLC | MAX | Class II | 2018-08-27 |
| K181386 | NuVasive Brigade Lateral System | Nu Vasive, Incorporated | OVD | Class II | 2018-08-24 |
| K172830 | Double Medical Femoral Nail System | Double Medical Technology, Inc. | HSB | Class II | 2018-08-24 |
| K180373 | CancelleX Porous Titanium Lumbar Interbody Device | Xenco Medical, LLC | MAX | Class II | 2018-08-24 |
| K181009 | APTUS CMC-I Fusion Plate System | Medartis AG | HRS | Class II | 2018-08-24 |
| K181035 | AOS Small Fragment Plating System Lite | Advanced Orthopaedic Solutions, Inc. (Aos) | HRS | Class II | 2018-08-24 |
| K180179 | Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird® NXG Spinal Fixation System; Phoenix® Minimally Invasive Spinal Fixation System; Phoenix® CDX Minimally Invasive Spinal Fixation System; JANUS® Midline Fixation Screw; JANUS® Fenestrated Screw | Orthofix, Inc. | NKB | Class II | 2018-08-24 |
| K181635 | GMK Sphere CR Tibial Inserts | Medacta International S.A. | JWH | Class II | 2018-08-23 |
| K173890 | GMK Sphere - Kinematic Alignment | Medacta International S.A. | JWH | Class II | 2018-08-23 |
| K181435 | ATEC Cervical Spacer System | Alphatec Spine, Inc. | ODP | Class II | 2018-08-21 |
| K181982 | MIDAScope and Introducer Kit, and MIDASystem | Intravu, Inc. | HRX | Class II | 2018-08-21 |
| K181306 | Actifuse Flow | Baxter Healthcare Corporation | MQV | Class II | 2018-08-17 |
| K181347 | Aries® Lumbar Interbodies | Osseus Fusion Systems, LLC | MAX | Class II | 2018-08-15 |
| K181792 | Duo Lumbar Interbody Fusion Device | Spineology, Inc. | MAX | Class II | 2018-08-14 |
| K180990 | TirboLOX-L Lumbar IBFD | Captiva Spine, Inc. | MAX | Class II | 2018-08-13 |
| K180539 | Deformity Analysis and Correction Software (DACS) and Instrumentation | Arrowhead Medical Device Technologies, LLC | OSN | Class II | 2018-08-13 |
| K181978 | Zenius, Iliad and Kora Spinal Fixation Systems | Medyssey USA, Inc. | NKB | Class II | 2018-08-13 |
| K180814 | CoreLink® M3 Stand-Alone Anterior Lumbar System | Corelink, LLC | OVD | Class II | 2018-08-10 |
| K181584 | Redi-Spine | Innovative Surgical Designs, Inc. | NKB | Class II | 2018-08-10 |
| K181680 | ICONN Answer II Suture Anchor | Iconn Orthopedics, LLC | MBI | Class II | 2018-08-09 |
| K180759 | SECULOK Suture Anchor | U&I Corporation | MBI | Class II | 2018-08-09 |
| K181533 | EVOS Wrist Fracture Plating System | Smith & Nephew, Inc. | HRS | Class II | 2018-08-09 |
| K181866 | MotoCLIP/HiMAX Step Staple Implant System | Crossroads Extremity Systems, LLC | JDR | Class II | 2018-08-09 |
| K181677 | Kodiak Spinal Fixation System | Alphatec Spine, Inc. | NKB | Class II | 2018-08-09 |
| K181557 | INFINITY Total Ankle System | Wrightmedicaltechnologyinc | HSN | Class II | 2018-08-09 |
| K173845 | Arthrex SwiveLock | Arthrex, Inc. | MBI | Class II | 2018-08-06 |
| K180853 | EP Granules BVF | Elute, Inc. | MQV | Class II | 2018-08-06 |
| K181425 | APTUS® Proximal Humerus System | Medartis AG | HRS | Class II | 2018-08-05 |
| K181549 | Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System) | Curiteva, LLC | KWQ | Class II | 2018-08-03 |
| K181809 | GRYPHON® Anchors with DYNACORD Suture | Medos International SARL | MAI | Class II | 2018-08-03 |
| K180777 | K2M Expandable Interbody System | K2m, Inc. | MAX | Class II | 2018-08-03 |
| K181146 | ASK System | L and K Biomed Corporation Limited | JWH | Class II | 2018-08-03 |
| K181562 | Curiteva Anterior Cervical Plate System | Curiteva, LLC | KWQ | Class II | 2018-08-02 |
| K180150 | PL8 Wrist Reconstruction Plate | Citieffe S.R.L. | HRS | Class II | 2018-08-02 |
| K181749 | SuperCable® Iso-Elastic Cerclage System | Kinamed, Incorporated | JDQ | Class II | 2018-08-01 |
| K181440 | Proficient® Posterior Cervical Spine System | Spine Wave, Inc. | NKG | Class II | 2018-07-30 |
| K181554 | Stowe Pedicle Screw System | Black Box Medical | NKB | Class II | 2018-07-27 |
| K180580 | Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices | Surgical Instrument Service and Savings, Inc. | KTT | Class II | 2018-07-27 |
| K181184 | OIC Intramedullary Nail System | The Orthopaedic Implant Company | HSB | Class II | 2018-07-27 |
| K180556 | Corelink Foundation 3D Anterior Lumbar System | Corelink, LLC | MAX | Class II | 2018-07-27 |
| K180076 | Ti 3Z Interbody System | Zavation Medical Products, LLC | MAX | Class II | 2018-07-27 |
| K173656 | Arthrex FibuLock Nail | Arthrex, Inc. | HSB | Class II | 2018-07-26 |
| K180960 | FIXIT / ComposiTCP Threaded Anchor System | S.B.M. Sas Sciences For Bio Materials | MAI | Class II | 2018-07-25 |
| K181453 | ATEC ALIF Spacer System | Alphatec Spine, Inc. | MAX | Class II | 2018-07-25 |
| K173947 | Lumbar Interbody Fusion System (OLLIF) | Advanced Research Medical, LLC | MAX | Class II | 2018-07-25 |
| K180632 | Exactech Equinoxe Small Reverse Shoulder System | Exactech, Inc. | PHX | Class II | 2018-07-25 |
| K181495 | Republic Spine Dark Star Spinal System | Republic Spine, LLC | NKB | Class II | 2018-07-25 |
| K180226 | TREND II Spinal Fixation System- STEP Series | Paonan Biotech Co., Ltd. | NKB | Class II | 2018-07-25 |
| K181399 | FIREFLY® Pedicle Screw Navigation Guide | Mighty Oak Medical, Inc. | PQC | Class II | 2018-07-24 |
| K181339 | Altus Spine Pedicle Screw System | Altus Partners, LLC | NKB | Class II | 2018-07-24 |
| K180544 | DePuy Synthes Static Staples | Synthes (USA) Products, LLC | JDR | Class II | 2018-07-24 |
| K181083 | Stryker All-PEEK Knotless Anchor System | Stryker | MBI | Class II | 2018-07-23 |
| K173645 | JASPER Spinal Fixation System | Gbs Commonwealth Co., Ltd. | NKB | Class II | 2018-07-23 |
| K180263 | EcoFit Vit E Acetabular System | Implantcast GmbH | LZO | Class II | 2018-07-20 |
| K181585 | JGH1 Core Deccompression Procedure Kit | AgNovos Healthcare USA, LLC | MQV | Class II | 2018-07-20 |
| K180022 | Athena Cervical Plate System | Medyssey USA, Inc. | KWQ | Class II | 2018-07-20 |
| K180763 | CuffLink Implant System Biocomposite | Conmed Corporation | MAI | Class II | 2018-07-19 |
| K181342 | JGH1 Bone Graft Substitute | AgNovos Healthcare USA, LLC | MQV | Class II | 2018-07-19 |
| K172857 | Latitud Hip Replacement System | Meril Healthcare Pvt. , Ltd. | LPH | Class II | 2018-07-19 |
| K173487 | CarboClear® Pedicle Screw System | CarboFix Orthopedics , Ltd. | NKB | Class II | 2018-07-18 |
| K181014 | Tritanium PL Cage | Stryker Spine | MAX | Class II | 2018-07-18 |
| K181079 | SeaSpine Regatta Lateral System | SeaSpine Orthopedics Corporation | MAX | Class II | 2018-07-18 |
| K180348 | Field Orthopaedics Micro Screw System | Field Orthopaedics Pty, Ltd. | HWC | Class II | 2018-07-17 |
| K181030 | Rubicon Lumbar Interbody Fusion System | Rubicon Spine, LLC | MAX | Class II | 2018-07-17 |
| K181375 | Apex Femoral Nailing System | Orthoxel | HSB | Class II | 2018-07-17 |
| K181600 | PathLoc-SI Joint Fusion System | L&K BIOMED Co., Ltd. | OUR | Class II | 2018-07-16 |
| K181115 | CxHA PEEK Cervical IBF System | Innovasis, Inc. | ODP | Class II | 2018-07-16 |
| K181063 | Kestrel Buttress Plate System | Innovasis, Inc. | KWQ | Class II | 2018-07-13 |
| K180655 | Viking Lumbar Polyaxial Screw System | Presidio Surgical | NKB | Class II | 2018-07-13 |
| K180673 | Normandy VBR System | Zavation Medical Products, LLC | PLR | Class II | 2018-07-13 |
| K173556 | Injection Screw | Biedermann Medtech, Inc. | HWC | Class II | 2018-07-13 |
| K181287 | Catalyst CSR Shoulder System | Catalyst Orthoscience, Inc. | KWT | Class II | 2018-07-12 |
| K180695 | FBC 921 (ALIF) | Fbc Device Aps | OVD | Class II | 2018-07-12 |
| K180730 | INVISION Total Ankle Revision System | Wrightmedicaltechnologyinc | HSN | Class II | 2018-07-11 |
| K180024 | SALVATION Midfoot Nail | Wrightmedicaltechnologyinc | HWC | Class II | 2018-07-11 |
| K180963 | ROCCIA ALIF, ROCCIA TLIF | Silony Medical GmbH | MAX | Class II | 2018-07-11 |
17,115 clearances in the Orthopedic panel. Data: openFDA.