Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 37
- Latest Decision
- 2018-07-10
Clearances · page 40 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K181246 | Zavation IBF System | Zavation Medical Products, LLC | MAX | Class II | 2018-07-10 |
| K181244 | Zavation Cervical Plate System | Zavation Medical Products, LLC | KWQ | Class II | 2018-07-10 |
| K180930 | EMPOWR VVC TIBIAL INSERT | Encore Medical L.P. | JWH | Class II | 2018-07-09 |
| K180798 | Prime Acetabular Cup System | Microport Orthopedics, Inc. | LPH | Class II | 2018-07-09 |
| K181261 | Curiteva Cervical Interbody Fusion System | Curiteva, LLC | ODP | Class II | 2018-07-09 |
| K181350 | ASTRA-OCT Spine System | Spinecraft, LLC | NKG | Class II | 2018-07-06 |
| K180755 | Vail ALIF Buttress Plate System | Evolution Spine, LLC | KWQ | Class II | 2018-07-06 |
| K180590 | Tyber Medical PT Interbody Spacer System | Tyber Medical, LLC | ODP | Class II | 2018-07-06 |
| K173970 | Materialise PKA Guide System | Materialise NV | HSX | Class II | 2018-07-06 |
| K181139 | OLYMPIC Posterior Spinal Fixation System | Astura Medical, LLC | NKB | Class II | 2018-07-06 |
| K173776 | BIOLOX delta Option and Extra-long Heads | Microport Orthopedics, Inc. | LZO | Class II | 2018-07-06 |
| K173864 | Peekplus® Interbody Fusion Device | Vallum Corporation | MAX | Class II | 2018-07-02 |
| K181410 | MotoCLIP/HiMAX Implant System | Crossroads Extremity Systems, LLC | JDR | Class II | 2018-06-29 |
| K181068 | CREO® Stabilization System, REVERE® Stabilization System | Globus Medical, Inc. | PGM | Class II | 2018-06-29 |
| K181203 | Juliet Ti | Spineart | MAX | Class II | 2018-06-28 |
| K180364 | HD LifeSciences Cervical IBFD System | Hd Lifesciences, LLC | ODP | Class II | 2018-06-27 |
| K181119 | Range (Denali and Mesa) Spinal Systems | K2m, Inc. | NKB | Class II | 2018-06-26 |
| K180674 | EVOL® ha-C Cervical Interbody Fusion System | Cutting Edge Spine, LLC | ODP | Class II | 2018-06-25 |
| K172788 | MONET Anterior Cervical Interbody Fusion Cage System | Ctl Medical Corporation | ODP | Class II | 2018-06-25 |
| K180724 | SPIRA Open Matrix LLIF | Camber Spine Technologies, LLC | MAX | Class II | 2018-06-25 |
| K180166 | Life Spine Lumbar Fixation System (SENTRY) | Life Spine, Inc. | KWQ | Class II | 2018-06-22 |
| K180493 | A3 Total Knee System | Beijing AK Medical Co., Ltd. | JWH | Class II | 2018-06-22 |
| K180594 | Knotless SutureTak Anchors | Arthrex, Inc. | MAI | Class II | 2018-06-22 |
| K173717 | Integra TITAN Reverse Shoulder System | Integra LifeSciences Corporation | PHX | Class II | 2018-06-21 |
| K172975 | DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins MR Conditional, DePuy Synthes Variable Angle Positioning Pins MR Conditional, DePuy Synthes Wire Mount MR Conditional, DePuy Synthes Cerclage Positioning Pin MR Conditional | Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. | JDQ | Class II | 2018-06-21 |
| K180377 | Fracture and Correction System | In2bones USA, LLC | HWC | Class II | 2018-06-20 |
| K181348 | Cartiva SCI Disposable Instrumentation Set | Cartiva, Inc. | QBO | Class II | 2018-06-20 |
| K180743 | Balanced Knee Revision System - Offset Junction Box | Ortho Development Corporation | JWH | Class II | 2018-06-20 |
| K172551 | Trinity PLUS Acetabular Shell | Corin U.S.A. Limited | LPH | Class II | 2018-06-15 |
| K180749 | Life Spine SIMPACT Sacroiliac Joint Fixation System | Life Spine, Inc. | OUR | Class II | 2018-06-15 |
| K181113 | CoLink Afx Plating System | In2bones USA, LLC | HRS | Class II | 2018-06-15 |
| K181280 | Patello-Femoral Wave (Kahuna) Arthroplasty System | Arthrosurface, Inc. | KRR | Class II | 2018-06-14 |
| K180401 | TiWAVE-C Porous Titanium Cervical Cage | Kalitec Direct, LLC | ODP | Class II | 2018-06-14 |
| K173455 | SurgTech Bipolar Head System | Surgtech, Inc. | KWY | Class II | 2018-06-14 |
| K180502 | S128 Anterior Lumbar Interbody Fusion (ALIF) System | Renovis Surgical Technologies, Inc. | OVD | Class II | 2018-06-14 |
| K180675 | Atlas Spine Expandable Cervical Interbody System | Atlas Spine, Inc. | ODP | Class II | 2018-06-13 |
| K180818 | Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) | Tenon Medical, Inc. | OUR | Class II | 2018-06-13 |
| K172833 | E-XPE Acetabular Components and U-Motion II Acetabular Cup | United Orthopedic Corporation | OQI | Class II | 2018-06-12 |
| K173787 | X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh System, BENGAL Stackable Cage System, BENGAL System, CONCORDE® System, CONCORDE® Inline Lumbar Interbody System, CONCORDE® Curve Lumbar Interbody System, CONCORDE® Bullet Lumbar Interbody System, COUGAR® System, COUGAR® LS Lateral Cage System, DEVEX® System, LEOPARD® System, DePuy PULSE Cervical Cage System, DePuy PULSE Lumbar Cage System, LUMBAR I/F CAGE® System | Medos International SARL | MQP | Class II | 2018-06-11 |
| K180766 | Endiscope, Endiscope Cervical | Elliquence, LLC | HRX | Class II | 2018-06-11 |
| K181281 | Altus Spine Pedicle Screw System | Altus Partners, LLC | NKB | Class II | 2018-06-11 |
| K173189 | Lumfuse TP | Precifit Medical, Ltd. | MAX | Class II | 2018-06-08 |
| K180612 | Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | HSX | Class II | 2018-06-07 |
| K180832 | SALVATION External Fixation System | Wrightmedicaltechnologyinc | KTT | Class II | 2018-06-06 |
| K180436 | T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System | Stryker Trauma GmbH | HSB | Class II | 2018-06-06 |
| K180500 | VariAx 2 System | Stryker GmbH | HWC | Class II | 2018-06-04 |
| K180464 | AEVUMED PHANTOM Suture Anchors | Aevumed, Inc. | MBI | Class II | 2018-05-31 |
| K170703 | Single Use Arthroscopic Electrode (with Pencil) | Modern Medical Equipment Manufacturing Limited | HRX | Class II | 2018-05-31 |
| K180480 | ATEC Universal Spacer System | Alphatec Spine, Inc. | PHM | Class II | 2018-05-31 |
| K180582 | Sternal Cable System | A & E Medical Corporation | JDQ | Class II | 2018-05-31 |
| K180361 | MICRORAPTOR REGENESORB Suture Anchor | Smith and Nephew, Inc. | MAI | Class II | 2018-05-30 |
| K181188 | EVEREST Spinal System | K2m, Inc. | NKB | Class II | 2018-05-30 |
| K173269 | KATOR Suture Anchor | Kator, LLC | MBI | Class II | 2018-05-30 |
| K173951 | Legend Acetabular Liners | Ortho Development Corporation | LPH | Class II | 2018-05-30 |
| K172871 | SpineKure Kyphoplasty System | Hanchang Co., Ltd. | NDN | Class II | 2018-05-29 |
| K181067 | AlignX Ankle Fusion System | Extremity Medical, LLC | HRS | Class II | 2018-05-23 |
| K173722 | PATRIOT COLONIAL Spacer, SUSTAIN Spacer | Globus Medical, Inc. | ODP | Class II | 2018-05-23 |
| K180662 | Arthrex FastThread Interference Screw | Arthrex, Inc. | MAI | Class II | 2018-05-22 |
| K180808 | Omni Foot Plating System | Extremity Medical, LLC | HRS | Class II | 2018-05-22 |
| K180220 | SAGICO OSI Spinal System by Osimplant | Spinal Analytics & Geometrical Implant Co, LLC | NKB | Class II | 2018-05-21 |
| K180817 | AERIAL Interspinous Fixation | Globus Medical, Inc. | PEK | Class II | 2018-05-21 |
| K180700 | KYPHON HV-R Bone Cement | Medtronic Sofamor Danek USA, Inc. | NDN | Class II | 2018-05-18 |
| K180876 | DTRAX Spinal System | Providence Medical Technology, Inc. | HRX | Class II | 2018-05-18 |
| K180087 | A.M. Surgical Intramedullary Fixation Device | A.M. Surgical, Inc. | HTY | Class II | 2018-05-18 |
| K173832 | InTice-C Porous Ti Cervical Interbody System | X-Spine Systems, Inc. | ODP | Class II | 2018-05-17 |
| K172480 | icotec Interbody Cage System | Icotec AG | ODP | Class II | 2018-05-17 |
| K172524 | Zimmer Persona Personalized Knee System | Zimmer, Inc. | MBH | Class II | 2018-05-17 |
| K180519 | HARRIER-SA Lumbar Interbody System | Choicespine, LP | OVD | Class II | 2018-05-16 |
| K180906 | Conformis iTotal Cruciate Retaining (CR) Knee Replacement System | Conformis, Inc. | JWH | Class II | 2018-05-16 |
| K180239 | Additive Orthopaedics Patient Specific 3D Printed Bone Segments | Additive Orthopaedics, LLC | HRS | Class II | 2018-05-16 |
| K180624 | Guided Growth Plate System Plus | Orthofix Srl | OBT | Class II | 2018-05-15 |
| K180687 | Reliance Lumber IBF System | Reliance Medical Systems | MAX | Class II | 2018-05-15 |
| K180686 | SeaSpine Daytona Small Stature Spinal System | SeaSpine Orthopedics Corporation | NKB | Class II | 2018-05-14 |
| K172583 | OrthoPediatrics PediNail Intramedullary Platform | Orthopediatrics, Inc. | HSB | Class II | 2018-05-10 |
| K180101 | HEALIX ADVANCE KNOTLESS BR Anchor | Medos International SARL | MAI | Class II | 2018-05-10 |
| K180642 | Pro-Link® Ti Stand-Alone Cervical Spacer System | Life Spine, Inc. | OVE | Class II | 2018-05-10 |
| K180932 | Diamond Orthopedic Bone Fixation Screws and Pins | Diamond Orthopedic, LLC | HWC | Class II | 2018-05-09 |
| K180929 | Klassic HD® Hip System | Total Joint Orthopedics, Inc. | LZO | Class II | 2018-05-09 |
| K173572 | DSM Biomedical Calcium Phosphate Cement with Microspheres | Kensey Nash Corporation Dba Dsm Biomedical | MQV | Class II | 2018-05-09 |
| K173311 | ARTHRO-Pump PA304 | W.O.M. World of Medicine GmbH | HRX | Class II | 2018-05-09 |
| K171690 | Trident Extremity Fixation System | Trident Orthopedics | HRS | Class II | 2018-05-08 |
| K172484 | A-CIFT SoloFuse | Spinefrontier, Inc. | OVE | Class II | 2018-05-08 |
| K173347 | STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX, ACTILIF M FLX, ACTILIF L FLX and ACTILIF Lateral-Oblique FLX | Centinel Spine, Inc. | MAX | Class II | 2018-05-08 |
| K180891 | EVOL Spinal Interbody System, EVOS Lumbar Interbody System | Cutting Edge Spine, LLC | MAX | Class II | 2018-05-04 |
| K173892 | NuVasive® XLX Interbody System | Nu Vasive, Incorporated | MAX | Class II | 2018-05-04 |
| K180437 | Hexanium® TLIF | Spinevision, S.A.S. | MAX | Class II | 2018-05-04 |
| K172568 | Cervage | Precifit Medical, Ltd. | ODP | Class II | 2018-05-04 |
| K180317 | EVOLUTION® Knee Systems MR Labeling, EVOLUTION® BIOFOAM® Tibial System, EVOLUTION® Revision Tibial System, EVOLUTION® Revision CCK System | Microport Orthopedics, Inc. | MBH | Class II | 2018-05-04 |
| K180071 | STYLO Interbody Fusion Device | Legend Spine Technologies | MAX | Class II | 2018-05-03 |
| K171151 | ACRON TLIF System | Spinemed Ges.M.B.H | MAX | Class II | 2018-04-27 |
| K180433 | ENNOVATE® | Aesculap Implant Systems, LLC | NKB | Class II | 2018-04-26 |
| K173201 | UNITY Sacroiliac Joint Fixation System | Huvexel Co. , Ltd. | OUR | Class II | 2018-04-26 |
| K170339 | Summit Hip System | DePuy Orthopaedics, Inc. | LZO | Class II | 2018-04-26 |
| K172633 | INFINITY Total Ankle System | Wrightmedicaltechnologyinc | HSN | Class II | 2018-04-26 |
| K180257 | InCore® Lapidus System | Nextremity Solutions, Inc. | HWC | Class II | 2018-04-25 |
| K180002 | Rampart One Lumbar Interbody Fusion Device | Spineology, Inc. | OVD | Class II | 2018-04-25 |
| K173782 | UNiD Patient Specific 3D printed cage | Medicrea International SA | MAX | Class II | 2018-04-25 |
| K172464 | XD880A Ultrasonic Osteotomy Surgical System | Morley Research Consortium | JDX | Class II | 2018-04-24 |
| K172699 | Agile Nail | Orthofix Srl | HSB | Class II | 2018-04-23 |
| K180090 | Cure Lumbar Plate System | Meditech Spine, LLC | KWQ | Class II | 2018-04-23 |
17,115 clearances in the Orthopedic panel. Data: openFDA.