Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 32
- Latest Decision
- 2018-11-16
Clearances · page 38 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K182179 | AdvantageRib Anterior System | Sig Medical Corp. | HRS | Class II | 2018-11-16 |
| K182109 | REDAPT Modular Acetabular Shell | Smith & Nephew, Inc. | LPH | Class II | 2018-11-16 |
| K181140 | Axis Chena Cervical PEEK Spacer System | Axis Orthopaedics | ODP | Class II | 2018-11-16 |
| K182182 | YUKON OCT Spinal System | K2m | NKG | Class II | 2018-11-15 |
| K183117 | PathLoc-L MIS Spinal System | L&K BIOMED Co., Ltd. | NKB | Class II | 2018-11-15 |
| K181829 | Velofix TLIF Cage | U&I Corporation | MAX | Class II | 2018-11-14 |
| K181963 | ostaPek Interbody Fusion Cages | Coligne AG | MAX | Class II | 2018-11-14 |
| K182882 | CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control | Conmed Corporation | HRX | Class II | 2018-11-14 |
| K182598 | VersaLink Fixation System | Premia Spine, Ltd. | NKB | Class II | 2018-11-13 |
| K182508 | Saxxony Posterior Cervical Thoracic System | Nexxt Spine, LLC | NKG | Class II | 2018-11-13 |
| K182195 | Arco-SA Lumbar Cage System | Neurostructures, Inc. | OVD | Class II | 2018-11-09 |
| K182808 | Aspida® Anterior Lumbar Plating System | Alphatec Spine, Inc. | KWQ | Class II | 2018-11-09 |
| K181590 | Neurostructures Cavetto® [MAX] Cervical Cage System | Neurostructures, Inc. | ODP | Class II | 2018-11-08 |
| K182462 | Exactech Alteon Highly Polished Femoral Stem | Exactech, Inc. | LZO | Class II | 2018-11-08 |
| K181819 | SMARTRELEASE Endoscopic Soft Tissue Release System | Microaire Surgical Instruments, LLC | HRX | Class II | 2018-11-06 |
| K181846 | ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP Anterior Cervical Plate System, XTEND Anterior Cervical Plate System, UNIFY Dynamic Anterior Cervical Plate System, CITADEL Anterior Lumbar Plate System, TRUSS Thoracolumbar Plate System, PLYMOUTH Thoracolumbar Plate System, SP-Fix Spinous Process Fixation Plate, RELIEVE Laminoplasty Fixation System | Globus Medical, Inc. | KWQ | Class II | 2018-11-06 |
| K181781 | DynaClipTM Bone Staple | MedShape, Inc. | JDR | Class II | 2018-11-05 |
| K181639 | Panta 2 Arthrodesis Nail System | Integra LifeSciences Corporation | HSB | Class II | 2018-11-02 |
| K181837 | Spinal Elements Ti-Bond coated devices | Spinal Elements, Inc. | MAX | Class II | 2018-11-02 |
| K182823 | PRODENSE Bone Graft Substitute | Wrightmedicaltechnologyinc | MQV | Class II | 2018-11-02 |
| K180310 | DePuy Synthes Trauma Orthopedic Plates and Screws | Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. | HRS | Class II | 2018-11-01 |
| K181820 | Medline Unite Mini Plates and Screws | Medline Industries, Inc. | HRS | Class II | 2018-11-01 |
| K182085 | Balanced Knee Revision System Trabecular Tibial Cone Augments | Ortho Development Corporation | JWH | Class II | 2018-10-31 |
| K182466 | AOS Calcaneal Plating System | Advanced Orthopaedic Solutions | HRS | Class II | 2018-10-30 |
| K180980 | ORTHROS Posterior Stabilization System; ORTHROS MIS Posterior Stabilization System | Camber Spine Technologies, LLC | NKB | Class II | 2018-10-27 |
| K181898 | Two-Step Implant System | Trilliant Surgical | HWC | Class II | 2018-10-26 |
| K181947 | Persona Revision Knee System | Zimmer, Inc. | JWH | Class II | 2018-10-25 |
| K182171 | SMV Scientific K-Wire and Pins | Summit Medventures | JDW | Class II | 2018-10-25 |
| K181530 | World Total Knee System | Signature Orthopaedics Pty, Ltd. | JWH | Class II | 2018-10-24 |
| K180758 | Osteocera Resorbable Bone Substitute | Wiltrom Corporation Limited | MQV | Class II | 2018-10-24 |
| K182322 | Duo Lumbar Interbody Fusion Device | Spineology, Inc. | MAX | Class II | 2018-10-24 |
| K182283 | FUSE Pedicle Screw System | Black Box Medical | NKB | Class II | 2018-10-23 |
| K173824 | Humeral Short Stem System | Shoulder Innovations, Inc. | MBF | Class II | 2018-10-23 |
| K181192 | PIP Fix | Hand Biomechanics Lab, Inc. | JEC | Class II | 2018-10-22 |
| K181254 | Quadra P | Medacta International S.A. | LZO | Class II | 2018-10-22 |
| K180554 | ANTHEM Fracture System | Globus Medical, Inc. | HRS | Class II | 2018-10-22 |
| K180213 | Titanium TomoFix Medial High Tibia Plate Anatomical | Synthes (USA) Products, LLC | HRS | Class II | 2018-10-19 |
| K181621 | Stable-C Interbody System | Nexus Spine, LLC | OVE | Class II | 2018-10-19 |
| K182264 | ICONN Revolution Knotless Suture Anchor | Iconn Orthopedics, LLC | MBI | Class II | 2018-10-19 |
| K182239 | OLYMPIC Posterior Spinal Fixation System | Astura Medical, LLC | NKB | Class II | 2018-10-18 |
| K181026 | OsteoBridge IDSF System | Merete GmbH | HSB | Class II | 2018-10-17 |
| K182240 | PASS LP Spinal System | Medicrea International SA | NKB | Class II | 2018-10-17 |
| K182154 | Depuy Synthes Femoral Neck System | Synthes (USA) Products, LLC | KTT | Class II | 2018-10-16 |
| K181815 | DynaBridge | Fusion Orthopedics, LLC | JDR | Class II | 2018-10-15 |
| K181640 | X-BOLT Hip Fracture Fixation System | X-Bolt Orthopaedics | HSB | Class II | 2018-10-12 |
| K181717 | Life Spine Laminoplasty System | Life Spine, Inc. | NQW | Class II | 2018-10-12 |
| K181569 | BKS Revision Sleeves System | Ortho Development Corporation | JWH | Class II | 2018-10-12 |
| K181607 | Thorecon Rigid Fixation System | A & E Medical Corporation | JDQ | Class II | 2018-10-12 |
| K180446 | b-ONE Total Knee System | B-One Ortho, Corp. | JWH | Class II | 2018-10-12 |
| K181644 | EIT Cellular Titanium® Lumbar Cage LLIF | Eit Emerging Implant Technologies GmbH | MAX | Class II | 2018-10-12 |
| K181999 | Integra TITAN Reverse Shoulder System | Integra LifeSciences Corporation | PHX | Class II | 2018-10-12 |
| K182536 | Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse Shoulder Humeral Liners , Exactech Equinoxe Small Reverse Shoulder Glenoid Plates , Exactech Equinoxe Reverse Shoulder Locking Cap | Exactech, Inc. | PHX | Class II | 2018-10-12 |
| K181091 | AxSOS 3 Ti | Stryker GmbH | HRS | Class II | 2018-10-11 |
| K182151 | MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate | Ctl Medical Corporation | OVE | Class II | 2018-10-11 |
| K182015 | Piccolo Composite® Plate System | CarboFix Orthopedics , Ltd. | HRS | Class II | 2018-10-11 |
| K172826 | Cellent Spinal Systems | Jiangsu Trauhui Medical Instrument Co., Ltd. | NKB | Class II | 2018-10-10 |
| K182492 | Geminus Volar Distal Radius Plate System | Skeletal Dynamics, LLC | HRS | Class II | 2018-10-10 |
| K181818 | Scarlet AL-T | Spineart | OVD | Class II | 2018-10-09 |
| K181603 | EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System | K2m, Inc. | NKG | Class II | 2018-10-05 |
| K181587 | ORTHOLOC SPS Shoulder Plating System | Tornier, Inc. | HRS | Class II | 2018-10-05 |
| K181531 | SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices | Spineex, Inc. | MAX | Class II | 2018-10-05 |
| K181860 | NuVasive Cohere Thoracolumbar Interbody System | Nu Vasive, Incorporated | MAX | Class II | 2018-10-05 |
| K180736 | WishBone Medical Plate and Screw System | Wishbone Medical, Inc. | HRS | Class II | 2018-10-04 |
| K181949 | SYMPHONY OCT System | Medos International SARL | NKG | Class II | 2018-10-04 |
| K182059 | Prase MIS Spinal System | Gbs Commonwealth Co., Ltd. | NKB | Class II | 2018-10-04 |
| K181883 | FIREFLY® Midline Navigation Guide | Mighty Oak Medical, Inc. | PQC | Class II | 2018-10-03 |
| K181881 | Outlet Sacroiliac Joint Fusion System | Sij Surgical | OUR | Class II | 2018-10-03 |
| K180972 | ARIX Clavicle System | Jeil Medical Corporation | HRS | Class II | 2018-10-03 |
| K181885 | Voyant System | Viseon, Inc. | HRX | Class II | 2018-10-02 |
| K182039 | Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay | Arthrex, Inc. | PHX | Class II | 2018-09-28 |
| K181746 | MICRORAPTOR Knotless Suture Anchor | Smith and Nephew, Inc. | MAI | Class II | 2018-09-28 |
| K180973 | Libertas Hip Replacement System | Maxx Orthopedics, Inc. | JDI | Class II | 2018-09-28 |
| K181794 | Truliant Porous Femoral Components | Exactech, Inc. | MBH | Class II | 2018-09-28 |
| K182377 | CarboClear® Pedicle Screw System | CarboFix Orthopedics , Ltd. | NKB | Class II | 2018-09-27 |
| K182370 | Acculoc Total Knee System | Rootloc Co., Ltd. | JWH | Class II | 2018-09-27 |
| K181397 | DualX | Innovasive, Inc. | MAX | Class II | 2018-09-27 |
| K181742 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) | Stryker GmbH | KWS | Class II | 2018-09-27 |
| K182402 | CoLink View Plating System | In2bones USA, LLC | HRS | Class II | 2018-09-27 |
| K181591 | Fixated Asfora BULLET CAGE® (FABC) | Medical Designs, LLC | MAX | Class II | 2018-09-26 |
| K181980 | OsseoScrew System | Alphatec Spine, Inc. | NKB | Class II | 2018-09-25 |
| K181611 | Comprehensive Reverse Shoulder System | Biomet Manufacturing Corp | PHX | Class II | 2018-09-24 |
| K181366 | REDAPT Porous Acetabular Shell | Smith & Nephew, Inc. | LPH | Class II | 2018-09-24 |
| K181702 | Tranquil-L Interbody System | Nexus Spine, LLC | MAX | Class II | 2018-09-21 |
| K181769 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | MBI | Class II | 2018-09-21 |
| K173960 | DePuy Corail AMT Hip Prosthesis | Depuy France S.A.S. | LZO | Class II | 2018-09-21 |
| K173898 | MicroPort Orthopedics Total Hip Systems MR Labeling | Microport Orthopedics Inc. (Mpo) | LZO | Class II | 2018-09-20 |
| K181995 | Chiral Surgical Pedicle Screw System | Chiral Surgical | NKB | Class II | 2018-09-20 |
| K181420 | Aequalis Flex Revive Shoulder System | Tornier, Inc. | KWS | Class II | 2018-09-20 |
| K181328 | T2 STRATOSPHERE Expandable Corpectomy System | Medtronic Sofamor Danek USA, Inc. | MQP | Class II | 2018-09-19 |
| K173982 | FORTIFY Corpectomy Spacers | Globus Medical, Inc. | MQP | Class II | 2018-09-19 |
| K181229 | TirboLOX-C Cervical IBFD | Captiva Spine, Inc. | ODP | Class II | 2018-09-19 |
| K181390 | Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System | OrthoPediatrics Corp. | NKB | Class II | 2018-09-18 |
| K181337 | Sypher Spacer System | Biogennix, LLC | MAX | Class II | 2018-09-18 |
| K171904 | Tandry Locking Plate System | Microware Precision Co., Ltd. | HRS | Class II | 2018-09-18 |
| K181721 | Ceracell Ortho Foam | Curasan AG | MQV | Class II | 2018-09-17 |
| K182260 | PALACOS MV | Heraeus Medical GmbH | LOD | Class II | 2018-09-17 |
| K181598 | Prime E-CLASS XLPE Liner | Microport Orthopedics, Inc. | LZO | Class II | 2018-09-14 |
| K173910 | Impress SFS System | Cable Fix Medical, LLC | JDQ | Class II | 2018-09-14 |
| K173933 | Sorrento Bioglass Bone Graft Substitute | Xenco Medical, LLC | MQV | Class II | 2018-09-13 |
| K180215 | DYNA-LINK ELITE Stand-Alone Anterior Lumbar System | Life Spine, Inc. | OVD | Class II | 2018-09-13 |
17,115 clearances in the Orthopedic panel. Data: openFDA.