Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 33
- Latest Decision
- 2020-03-11
Clearances · page 31 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K192810 | Apollo Suture Anchor System | Valeris Medical | MBI | Class II | 2020-03-11 |
| K192484 | Fixone Biocomposite Anchor | Aju Pharm Co., Ltd. | MAI | Class II | 2020-03-11 |
| K200328 | Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System | Kyocera Medical Technologies, Inc. | OQG | Class II | 2020-03-11 |
| K200048 | MectaLIF Anterior Simple | Medacta International S.A. | MAX | Class II | 2020-03-09 |
| K191655 | MEGAFIX® Pedicle Screw Spinal System | Seohancare Co., Ltd. | NKB | Class II | 2020-03-06 |
| K200267 | LOSPA® IS Spinal Fixation System | Corentec Co., Ltd. | NKB | Class II | 2020-03-06 |
| K190652 | OSSIOfiber Hammertoe Fixation System/OSSIOfiber Hammertoe Fixation Implant | OSSIO , Ltd. | HTY | Class II | 2020-03-06 |
| K193402 | ALLthread PEEK Suture Anchor | Biomet, Inc. | MBI | Class II | 2020-03-05 |
| K191709 | V-STRUT Vertebral Implant | Hyprevention Sas | NDN | Class II | 2020-03-05 |
| K200028 | Coronet Soft Tissue Fixation System | Conextions Medical | MBI | Class II | 2020-03-04 |
| K191525 | KinematX Total Wrist Arthroplasty System | Extremity Medical, LLC | JWJ | Class II | 2020-03-04 |
| K192906 | Mecta-C Stand Alone | Medacta International S.A. | OVE | Class II | 2020-03-04 |
| K193616 | ARIX Ankle System | Jeil Medical Corporation | HRS | Class II | 2020-03-04 |
| K192032 | Fixone Biocomposite Small Anchor | Aju Pharm Co., Ltd. | MAI | Class II | 2020-03-03 |
| K193256 | Anjon Bremer Halo System | Anjon Holdings, LLC | JEC | Class II | 2020-03-02 |
| K193378 | CarboClear Lumbar Cage System | CarboFix Orthopedics , Ltd. | MAX | Class II | 2020-03-02 |
| K200381 | Daytona® Small Stature Spinal System | SeaSpine Orthopedics Corporation | NKB | Class II | 2020-02-28 |
| K193029 | CONQUEST FN | Smith & Nephew, Inc. | JDO | Class II | 2020-02-28 |
| K192570 | Atlas Spine Expandable Cervical Standalone Interbody System | Atlas Spine, Inc. | OVE | Class II | 2020-02-28 |
| K192660 | Zimmer M/L Taper Hip Prosthesis | Zimmer, Inc. | LZO | Class II | 2020-02-28 |
| K192447 | Superelastic Staple | Neosteo | JDR | Class II | 2020-02-28 |
| K192683 | Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads | Biomet UK, Ltd. | LZO | Class II | 2020-02-27 |
| K192619 | Pitkar Locked Plating System | S.H.Pitkar Orthotools Pvt. , Ltd. | HRS | Class II | 2020-02-27 |
| K192096 | Omnia Medical Trauma Screws | Omnia Medical, LLC | HWC | Class II | 2020-02-27 |
| K193506 | NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System | Nu Vasive, Incorporated | MQP | Class II | 2020-02-26 |
| K191463 | DePuy Synthes Hammertoe Continuous Compression Implant | Synthes (USA) Products, LLC | JDR | Class II | 2020-02-26 |
| K193414 | Trigon HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. | PLF | Class II | 2020-02-25 |
| K192855 | DELTA XTEND(TM) Reverse Shoulder System | Depuy(Ireland) | PHX | Class II | 2020-02-24 |
| K193412 | NEXXT MATRIXX System | Nexxt Spine, LLC | PLR | Class II | 2020-02-24 |
| K193180 | Alliance Augmented Glenoid | Zimmer, Inc. | KWS | Class II | 2020-02-24 |
| K193451 | Titanium Interference Screws | Biomet, Inc. | HWC | Class II | 2020-02-24 |
| K193308 | T2 Alpha Tibia Nailing System, IMN Screws System | Stryker Trauma GmbH | HSB | Class II | 2020-02-23 |
| K192799 | Glenoid Baseplate with Screw | Fx Shoulder USA, Inc. | PHX | Class II | 2020-02-21 |
| K190363 | Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical TiBrid ALIF Cage, Omnia Medical TiBrid PLIF Cage, Omnia Medical TiBrid TLIF Cage | Omnia Medical, LLC | MAX | Class II | 2020-02-21 |
| K193533 | WIN Flexible Nail System | Biomet, Inc. | JDS | Class II | 2020-02-20 |
| K193255 | Largo PEEK Interbody System | Flospine, LLC | MAX | Class II | 2020-02-20 |
| K193098 | Exactech® Equinoxe® Reverse Shoulder Glenospheres | Exactech, Inc. | PHX | Class II | 2020-02-20 |
| K193203 | MOJAVE Expandable Interbody System | K2m, Inc. | MAX | Class II | 2020-02-18 |
| K193554 | APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 System | Medartis AG | HRS | Class II | 2020-02-16 |
| K193245 | Dunamis PunchTac Suture Anchors | Dunamis, LLC | MBI | Class II | 2020-02-14 |
| K193168 | Agilon Moldable | Biogennix, LLC | MQV | Class II | 2020-02-13 |
| K193224 | Daytona® Small Stature Growth Rod Conversion Set | SeaSpine Orthopedics Corporation | PGM | Class II | 2020-02-13 |
| K191966 | NewPrim System | Brm Extremities | KWH | Class II | 2020-02-13 |
| K193472 | OrthoCircle Spine Pedicle Screw System | Orthocircle Spine | NKB | Class II | 2020-02-13 |
| K193156 | Arthrex Mini Comprehensive Fixation System - 1.0mm Screws | Arthrex, Inc. | HWC | Class II | 2020-02-10 |
| K200130 | M.U.S.T. MINI Posterior Cervical Screws System | Medacta International S.A. | NKG | Class II | 2020-02-10 |
| K193165 | MectaFix CL Fixation Button with Continuous Loop | Medacta International S.A. | MBI | Class II | 2020-02-10 |
| K193129 | Yukon OCT Spinal System | K2m, Inc. | NKG | Class II | 2020-02-07 |
| K193461 | MectaLock All-Suture Anchors | Medacta International S.A. | MBI | Class II | 2020-02-06 |
| K193521 | Steerable Plateau Ti | Life Spine, Inc. | MAX | Class II | 2020-02-06 |
| K200170 | SpineNet SSP System | Spinenet, LLC | KWQ | Class II | 2020-02-05 |
| K193396 | PERLA® TL posterior osteosynthesis system | Spineart | NKB | Class II | 2020-02-05 |
| K193320 | KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System | Kyocera Medical Technologies, Inc. | OVD | Class II | 2020-02-04 |
| K193398 | Summit DuoFix HA Coating | DePuy Orthopaedics, Inc. | MEH | Class II | 2020-02-04 |
| K190842 | Comus Locking Plate systems | Jiangsu Trauhui Medical Instrument Co., Ltd. | HRS | Class II | 2020-02-03 |
| K193258 | ProLift Expandable System | Life Spine, Inc. | MAX | Class II | 2020-01-31 |
| K193284 | Physica LMC Knee System | Lima Corporate S.P.A. | JWH | Class II | 2020-01-31 |
| K192163 | TTC Phantom® Intramedullary Nail System | Paragon 28, Inc. | HSB | Class II | 2020-01-31 |
| K193270 | CapLOX II®/TowerLOX® MIS Pedicle Screw System | Captiva Spine, Inc. | NKB | Class II | 2020-01-31 |
| K190956 | SCS 17-01 | Anika Therapeutics, Inc. | MQV | Class II | 2020-01-30 |
| K193057 | ATTUNE All-Polyethylene Tibia | Depuy Ireland UC | JWH | Class II | 2020-01-30 |
| K193099 | Anatomical Shoulder System | Zimmer GmbH | PHX | Class II | 2020-01-29 |
| K191677 | MectaTap TI Suture Anchor | Medacta International S.A. | MBI | Class II | 2020-01-29 |
| K191380 | Quantum® Total Ankle Prosthesis | In2bones Sas | HSN | Class II | 2020-01-29 |
| K193365 | M.U.S.T. Pedicle Screw System | Medacta International S.A. | NKB | Class II | 2020-01-27 |
| K192014 | SYPMHONY OCT System | Medos International SARL | NKG | Class II | 2020-01-24 |
| K193223 | Persona Personalized Knee System | Zimmer, Inc. | JWH | Class II | 2020-01-24 |
| K192984 | APTUS Clavicle System | Medartis AG | HRS | Class II | 2020-01-24 |
| K191227 | Paratrooper Plantar Plate Repair System | Paragon 28, Inc. | MBI | Class II | 2020-01-24 |
| K193295 | Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor | Parcus Medical, LLC | MBI | Class II | 2020-01-23 |
| K192502 | Anatomic PEEK Cervical Fusion System, Anatomic PEEK PTC Cervical Fusion System, Capstone Spinal System, Capstone PTC Spinal System, Capstone Control Spinal System, Capstone Control PTC Spinal System, Clydesdale Spinal System, Clydesdale PTC Spinal System, Cornerstone PSR Cervical Fusion System, Crescent Spinal System, Crescent Spinal System Titanium, Divergence Anterior Cervical Fusion System (For Stand-Alone Interbody Device Only), Divergence-L Anterior/Oblique Lumbar Fus | Medtronic Sofamor Danek USA, Inc. | MAX | Class II | 2020-01-22 |
| K192993 | SCARLET AL-T | Spineart | OVD | Class II | 2020-01-22 |
| K193606 | Y-Knot OneStep Anchor | Conmed Corporation | MBI | Class II | 2020-01-22 |
| K193370 | Nexxt Matrixx System | Nexxt Spine, LLC | MAX | Class II | 2020-01-21 |
| K193222 | Tyber Medical Anatomical Plating System | Tyber Medical, LLC | HRS | Class II | 2020-01-20 |
| K193543 | CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx Plating System | In2bones USA, LLC | HRS | Class II | 2020-01-17 |
| K192750 | AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip | Parcus Medical, LLC | MBI | Class II | 2020-01-16 |
| K192942 | ALLthread Titanium Suture Anchor | Biomet, Inc. | MBI | Class II | 2020-01-16 |
| K191831 | MobiliT Cup | Corin U.S.A. Limited | LZO | Class II | 2020-01-16 |
| K190981 | NEX-D2 Posterior Fixation System | Next Orthosurgical | NKB | Class II | 2020-01-15 |
| K193503 | Arthrex SwiveLock Suture Anchor | Arthrex, Inc. | MAI | Class II | 2020-01-15 |
| K192115 | SABLE Expandable Spacer | Globus Medical, Inc. | MAX | Class II | 2020-01-14 |
| K192800 | Streamline TL Spinal Fixation System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | NKB | Class II | 2020-01-14 |
| K193645 | nva, nvp, and nvt | Nvision Biomedical Technologies, Inc. | MAX | Class II | 2020-01-13 |
| K193011 | CD Horizon Fenestrated Screw Set | Medtronic Sofamor Danek USA, Inc. | NKB | Class II | 2020-01-10 |
| K192995 | OsteoRemedies Hip Spacer System | Osteoremedies, LLC | KWL | Class II | 2020-01-10 |
| K193452 | MotoBAND CP Implant System | Crossroads Extemity Systems, LLC | HRS | Class II | 2020-01-10 |
| K193372 | Univers Revers Modular Glenoid System (Augemented baseplates) | Arthrex, Inc. | PHX | Class II | 2020-01-10 |
| K193465 | CorticaLINK Spinal Fusion Platform | Spine Smith Holdings, LLC | NKB | Class II | 2020-01-10 |
| K192363 | Altapore | Baxter Healthcare Corporation | MQV | Class II | 2020-01-09 |
| K193433 | AMIStem-C | Medacta International S.A. | LZO | Class II | 2020-01-09 |
| K192975 | Tyber Medical Trauma Screws | Tyber Medical, LLC | HWC | Class II | 2020-01-09 |
| K192687 | TrellOss-L MPF | Nexxt Spine, LLC | MAX | Class II | 2020-01-09 |
| K191581 | Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device | Titan Spine, Inc. | OVD | Class II | 2020-01-08 |
| K191489 | Genesys Spine 3DP Cervical Interbody System | Genesys Spine | OVE | Class II | 2020-01-08 |
| K192974 | Tyber Medical Trauma Screw | Tyber Medical, LLC | HWC | Class II | 2020-01-08 |
| K192754 | Avenger Radial Head System | In2bones USA, LLC | KWI | Class II | 2020-01-07 |
| K192497 | EVOL ha - D Lateral Interbody Fusion System | Cutting Edge Spine, LLC | MAX | Class II | 2020-01-06 |
| K192827 | Quadra-P | Medacta International S.A. | LZO | Class II | 2020-01-06 |
| K192696 | TriMed ASET Foot Plating System | TriMed, Inc. | HRS | Class II | 2020-01-05 |
17,115 clearances in the Orthopedic panel. Data: openFDA.