Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 33
- Latest Decision
- 2021-05-04
Clearances · page 25 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K201671 | A-Link Z | Acuity Surgical Devices, LLC | OVD | Class II | 2021-05-04 |
| K210290 | JACE Medical Thoracic Plating System | Jace Medical, LLC | HRS | Class II | 2021-04-30 |
| K210247 | OsteoCentric Integrated Hip Fastener System | Osteocentric Technologies D.B.A. Osteocentric Trauma | JDO | Class II | 2021-04-30 |
| K210061 | ProLift Lateral HELO Fixated | Life Spine, Inc. | MAX | Class II | 2021-04-30 |
| K210637 | CD Horizon Spinal System | Medtronic | NKB | Class II | 2021-04-30 |
| K201024 | Expandable Titanium PLIF/TLIF System | Spectrum Spine, LLC | MAX | Class II | 2021-04-29 |
| K203532 | BI-MENTUM ALTRX® Dual Mobility Liner | Depuy Ireland UC | LZO | Class II | 2021-04-28 |
| K200391 | MPACT Extension | Medacta International S.A. | LPH | Class II | 2021-04-28 |
| K203121 | Responsive Arthroscopy Thunderbolt System | Responsive Arthroscopy, LLC | MBI | Class II | 2021-04-27 |
| K210890 | GPS Cervical Spacers | G Surgical, LLC | ODP | Class II | 2021-04-23 |
| K203605 | SteriTrak | Arbutus Medical, Inc. | JEC | Class II | 2021-04-23 |
| K210549 | ARx Spinal System | Life Spine, Inc. | NKB | Class II | 2021-04-22 |
| K210482 | Medline UNITE REFLEX Nitinol Staple System | Medline Industries, Inc. | JDR | Class II | 2021-04-22 |
| K210893 | Restoration Anatomic Shell | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | LPH | Class II | 2021-04-22 |
| K210483 | MOBIO Total Knee System | B-One Ortho, Corp. | JWH | Class II | 2021-04-21 |
| K202639 | si-Mochi | Biostone, Ltd. | MQV | Class II | 2021-04-21 |
| K210961 | U2 Total Knee System, XPE Tibial Insert, PS PLUS | United Orthopedic Corporation | JWH | Class II | 2021-04-21 |
| K210157 | SOLE Medial Column Fusion Plate | Orthofix Srl | HRS | Class II | 2021-04-20 |
| K210427 | M.U.S.T. Midline Cortical (MC) Screw System | Medacta International S.A. | NKB | Class II | 2021-04-20 |
| K210420 | Goblin and Goblin LS Pedicle Screw Systems | Medynus, Inc. | NKB | Class II | 2021-04-19 |
| K203495 | Arthrex SwiveLock Anchor | Arthrex, Inc. | MAI | Class II | 2021-04-19 |
| K203421 | Triathlon AS-1 | Conformis, Inc. | OOG | Class II | 2021-04-19 |
| K201047 | Fusion Taper System | Signature Orthopaedics Pty, Ltd. | LZO | Class II | 2021-04-16 |
| K210539 | CoreLink Midline Fixation System | Corelink, LLC | NKB | Class II | 2021-04-15 |
| K203315 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | KWS | Class II | 2021-04-15 |
| K210754 | Cannulated Fasteners and Nuts | OsteoCentric Technologies | HWC | Class II | 2021-04-14 |
| K210658 | Volition Plating System | Ortho Solutions UK , Ltd. | HRS | Class II | 2021-04-13 |
| K200919 | Idys ALIF 3DTi | Clariance | MAX | Class II | 2021-04-12 |
| K210456 | Ligament Staple | Medacta International S.A. | JDR | Class II | 2021-04-12 |
| K203742 | IdentiTi ALIF Standalone Interbody System | Alphatec Spine, Inc. | OVD | Class II | 2021-04-09 |
| K210408 | DePuy Synthes Variable Angle Locking Patella Plating System | Synthes (USA) Products, LLC | HRS | Class II | 2021-04-08 |
| K210182 | PANAMA Anterior Cervical Plate (ACP) System | Flospine | KWQ | Class II | 2021-04-07 |
| K203520 | Blustone Synergy Interbody Fusion System | Blustone Synergy, LLC | ODP | Class II | 2021-04-07 |
| K210554 | Physica system | Lima Corporate S.P.A. | MBH | Class II | 2021-04-06 |
| K210716 | CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments | CarboFix Orthopedics , Ltd. | NKB | Class II | 2021-04-06 |
| K203673 | MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MySpine S2-Alar/Alar Iliac Guides) | Medacta International S.A. | PQC | Class II | 2021-04-06 |
| K201457 | Auxein Brand Vertaux 5.5 mm Pedicle Screw System | Auxein Medical Private Limited/71164 | NKB | Class II | 2021-04-06 |
| K203480 | DOUBLEFLO system | Hemodia Sas | HRX | Class II | 2021-04-05 |
| K203472 | KMTI Hip Replacement System | Kyocera Medical Technologies, Inc. | OQG | Class II | 2021-04-02 |
| K203230 | Global Shoulder and Delta CTA systems | Depuy Lnc. | KWS | Class II | 2021-04-02 |
| K201611 | Apex Knee System | Omnilife Science | JWH | Class II | 2021-04-02 |
| K210784 | Extended HA Half Pins | Smith & Nephew, Inc. | JDW | Class II | 2021-04-02 |
| K210275 | Polaris Spinal System | Zimmer Biomet Spine, Inc. | NKB | Class II | 2021-04-02 |
| K202768 | KOSMO Femoral Stem | B-One Ortho, Corp. | LZO | Class II | 2021-04-01 |
| K202032 | Idys LLIF 3DTi | Clariance, Sas | OVD | Class II | 2021-04-01 |
| K210308 | EMPOWR Porous Femur with HAnano SurfaceTM | Encore Medical L.P. | MBH | Class II | 2021-03-30 |
| K210207 | Humeral Eccentric Reverse Metaphysis | Medacta International S.A. | PHX | Class II | 2021-03-26 |
| K203254 | Lucent 3D Spinal System | Spinal Elements, Inc. | MAX | Class II | 2021-03-26 |
| K210205 | DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System | Synthes (USA) Products, LLC | HRS | Class II | 2021-03-26 |
| K203038 | Toro-L Interbody Fusion System | Integrity Implants, Inc. | MAX | Class II | 2021-03-26 |
| K210534 | GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System | Gramercy Extremity Orthopedics, LLC | HRS | Class II | 2021-03-26 |
| K203259 | FairFix Adjustable Button System | Medacta International S.A. | MBI | Class II | 2021-03-26 |
| K210566 | LEGION Porous CR Narrow Femoral Components | Smith & Nephew, Inc. | MBH | Class II | 2021-03-25 |
| K210667 | FIREBIRD SI Fusion System | Orthofix, Inc. | OUR | Class II | 2021-03-25 |
| K203834 | Arthrex Patella SuturePlates | Arthrex, Inc. | HRS | Class II | 2021-03-25 |
| K210498 | Betta Link Knotless Implant System | T.A.G. Medical Products Corporation, Ltd. | MBI | Class II | 2021-03-24 |
| K210325 | APOLLO Anterior Cervical Plate (ACP) System | Aurora Spine, Inc. | KWQ | Class II | 2021-03-23 |
| K203780 | Harvester SI: Sacroiliac Fixation System | Spinus International, Inc. | OUR | Class II | 2021-03-23 |
| K210120 | BonOs HV, BonOs MV, BonOs LV | Osartis GmbH | LOD | Class II | 2021-03-19 |
| K210125 | BonOs HV Genta, BonOs MV Genta, BonOs LV Genta | Osartis GmbH | LOD | Class II | 2021-03-19 |
| K203342 | CONSTRUX Mini Ti Spacer System | Orthofix, Inc. | ODP | Class II | 2021-03-18 |
| K210286 | Cure 2.0 Anterior Cervical Plate (ACP) System | Meditech Spine, LLC | KWQ | Class II | 2021-03-18 |
| K210551 | Persona Revision Knee System | Zimmer, Inc. | JWH | Class II | 2021-03-18 |
| K203444 | BEE HA Cage | NGMedical GmbH | ODP | Class II | 2021-03-18 |
| K210449 | Infinity OCT System, PASS OCT® Spinal System | Medtronic | NKG | Class II | 2021-03-18 |
| K210285 | Adaptable Ortho Innovations Intramedullary Nail System | Adaptable Ortho Innovations, LLC | HSB | Class II | 2021-03-18 |
| K203361 | ProLift Wedge Expandable Spacer System | Life Spine, Inc. | MAX | Class II | 2021-03-17 |
| K210193 | DB-Composite | Dimensional Bioceramics, LLC | MQV | Class II | 2021-03-15 |
| K203697 | BC Reflex Uni Knee System | Bodycad Laboratories, Inc. | HSX | Class II | 2021-03-12 |
| K210060 | CoLink Mfx Implant System | In2bones USA, LLC | HRS | Class II | 2021-03-12 |
| K210078 | Stryker ProCinch Adjustable Loop Device | Stryker Endoscopy | MBI | Class II | 2021-03-11 |
| K202815 | PROPHECY Preoperative Navigation Alignment System | Wrightmedicaltechnologyinc | HSN | Class II | 2021-03-10 |
| K203065 | Lumbar Spine Truss System Plating Solution (LSTS-PS) | 4Web, Inc. | KWQ | Class II | 2021-03-10 |
| K210359 | Hexanium TLIF | Spinevision, S.A.S. | MAX | Class II | 2021-03-10 |
| K201728 | Versalock Periprosthetic Femur Plates System-GMReis | GM Dos Reis Industria e Comercio Ltda. | HRS | Class II | 2021-03-08 |
| K210390 | Apex 3D Total Ankle Replacement System | Paragon 28, Inc. | HSN | Class II | 2021-03-06 |
| K201420 | Republic Spine Dark Star Spinal System | Republic Spine, LLC | NKB | Class II | 2021-03-05 |
| K210043 | LOQTEQ Distal Lateral Femur Plate 4.5 System | Aap Implantate AG | HRS | Class II | 2021-03-03 |
| K203576 | FORZA Ti Spacer System | Orthofix, Inc. | MAX | Class II | 2021-03-03 |
| K210010 | GMK Revision & Hinge Extension - TiNbN Coating | Medacta International S.A. | KRO | Class II | 2021-03-02 |
| K203755 | Shoulder System - TiNbN Coating | Medacta International S.A. | PHX | Class II | 2021-03-02 |
| K202889 | Able Medical Devices Valkyrie Thoracic Fixation System | Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices | HRS | Class II | 2021-03-02 |
| K210271 | NuVasive Modulus ALIF System | Nu Vasive, Incorporated | OVD | Class II | 2021-03-01 |
| K203819 | T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Tibial Nailing System, T2 Femoral System, T2 Supracondylar Nail System | Stryker GmbH | HSB | Class II | 2021-02-26 |
| K210268 | LTJ Screws and Washer | Azurmeds, Inc. | HWC | Class II | 2021-02-26 |
| K203247 | iFuse-TORQ Implant System | SI-BONE, Inc. | OUR | Class II | 2021-02-25 |
| K210239 | CITRESPLINE and CITRELOCK ACL Implants | Acuitive Technologies, Inc. | MAI | Class II | 2021-02-24 |
| K203479 | ExtremiLOCK Lateral Ankle Fusion Plates | Osteomed | HRS | Class II | 2021-02-24 |
| K203493 | MectaLock Extension | Medacta International S.A. | MAI | Class II | 2021-02-22 |
| K200062 | Foot and Ankle System | Leith Medical, LLC | HRS | Class II | 2021-02-22 |
| K202662 | Parcus Titanium Interference Screws | Parcus Medical, LLC | MBI | Class II | 2021-02-22 |
| K210155 | Duo Expandable Interbody Fusion System | Spineology, Inc. | MAX | Class II | 2021-02-19 |
| K202232 | Comprehensive Vault Reconstruction System | Biomet Manufacturing Corp | PHX | Class II | 2021-02-19 |
| K201379 | Artemis Proximal Femoral Nail System | Glw, Inc. | HSB | Class II | 2021-02-19 |
| K210167 | DELTA XTEND Reverse Shoulder System | DePuy Orthopaedics, Inc. | PHX | Class II | 2021-02-19 |
| K202380 | Born PT-LIF Cage HA | Spineworxx AG | MAX | Class II | 2021-02-19 |
| K201274 | Ultrasonic Osteotomy Surgical System | Smtp Technology Co., Ltd. | JDX | Class II | 2021-02-19 |
| K210192 | A.L.P.S. Clavicle Plating System | Biomet, Inc. | HRS | Class II | 2021-02-19 |
| K202498 | 4CIS SARA Spine System, 4CIS VERTU Spine System | Solco Biomedical Company India Private Limited | NKB | Class II | 2021-02-18 |
| K202338 | SpaceFlex Shoulder | G21, S.R.L. | MBB | Class II | 2021-02-17 |
17,115 clearances in the Orthopedic panel. Data: openFDA.