Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 31
- Latest Decision
- 2017-10-23
Clearances · page 44 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K172343 | Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology | Rti Surgical, Inc. | MAX | Class II | 2017-10-23 |
| K171640 | M-ARS ACL: Anatomic Ribbon Surgery System | Medacta International S.A. | MBI | Class II | 2017-10-23 |
| K171489 | Acapella Cervical Spacer System | Choicespine, LP | OVE | Class II | 2017-10-23 |
| K170106 | MyKnee PPS-Pin Positioners | Medacta International S.A. | JWH | Class II | 2017-10-20 |
| K172806 | Bencox Mirabo Cup System | Corentec Co., Ltd. | LPH | Class II | 2017-10-17 |
| K172186 | BioWick X Implant with Driver | Cayenne Medical, Inc. | MBI | Class II | 2017-10-16 |
| K163653 | NOVOS-NAIL Limb Lengthening System (LLS) | Smith & Nephew | HSB | Class II | 2017-10-13 |
| K170146 | Galaxy UNYCO System | Orthofix Srl | KTT | Class II | 2017-10-12 |
| K171497 | Mikron Spinal Fixation System | Mikron Makina Sanayi Ticaret Co. , Ltd. | MNI | Class II | 2017-10-12 |
| K172123 | NuVasive® Modulus XLIF Interbody System | Nu Vasive, Incorporated | MAX | Class II | 2017-10-11 |
| K172724 | XIA® 4.5 Spinal System, Power Adaptor Instrument Accessory | Stryker Corporation | NKB | Class II | 2017-10-10 |
| K170089 | U-Motion II Acetabular System Additional sizes | United Orthopedic Corporation | LZO | Class II | 2017-10-06 |
| K170452 | Medacta Shoulder System | Medacta International S.A. | PHX | Class II | 2017-10-05 |
| K170344 | Tahoe Uni Knee System | Consensus Orthopedics, Inc. | HSX | Class II | 2017-10-05 |
| K171689 | ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology | Medtronic Sofamor Danek USA, Inc. | MAX | Class II | 2017-10-05 |
| K172408 | Biomet Bone Cement R | Biomet, Inc. | LOD | Class II | 2017-10-05 |
| K163366 | Shanghai Sanyou CARMEN Cervical Fusion System | Shanghai Sanyou Medical Co, Ltd. | KWQ | Class II | 2017-10-05 |
| K172092 | Reprocessed Shavers/Burs | Renovo, Inc. | HRX | Class II | 2017-10-04 |
| K171991 | EMPOWR Porous Knee System | Encore Medical L.P. | MBH | Class II | 2017-10-04 |
| K172684 | Smith & Nephew, Inc. ANTHOLOGY AFIT Hip Stem | Smith & Nephew, Inc. | LPH | Class II | 2017-10-03 |
| K172210 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) | Stryker Trauma AG | KWS | Class II | 2017-10-02 |
| K172596 | Large Screws Range | Newclip Technics | HWC | Class II | 2017-10-02 |
| K171768 | Trident® II Acetabular System | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | LPH | Class II | 2017-10-02 |
| K171250 | BRIDALVEIL Occipital Cervical Thoracic System | Astura Medical | NKG | Class II | 2017-10-02 |
| K172065 | SCARLET AC-T | Spineart | ODP | Class II | 2017-09-29 |
| K170119 | Calix Lumbar Spinal Implant System | X-Spine Systems, Inc. | MAX | Class II | 2017-09-29 |
| K172612 | FiberTak DX | Arthex, Inc. | MBI | Class II | 2017-09-28 |
| K170802 | TRAUMACEM V+ Injectable Bone Cement | Synthes (USA) Products, LLC | LOD | Class II | 2017-09-28 |
| K171894 | NuVasive® Precept Spinal System | Nu Vasive, Incorporated | NKB | Class II | 2017-09-28 |
| K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | MAX | Class II | 2017-09-28 |
| K172275 | Vitality® Spinal Fixation System, Vitality®+ Power Instrument System | Zimmer Biomet Spine, Inc. | NKB | Class II | 2017-09-27 |
| K171211 | OIC External Fixation System | Orthopaedic Implant Company | KTT | Class II | 2017-09-27 |
| K170482 | Spider Frame External Fixation System | Tasarimmed Tibbi Mamuller Sanayi VE Ticaret A.S | KTT | Class II | 2017-09-27 |
| K171107 | CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System | Medtronic Sofamor Danek USA, Inc. | MAX | Class II | 2017-09-26 |
| K172101 | ROMEO® 2 Posterior Osteosynthesis System | Spineart | NKB | Class II | 2017-09-26 |
| K171161 | Dimensional Bioceramics Calcium Sulfate Device (DB-CSD) | Dimensional Bioceramics, LLC | MQV | Class II | 2017-09-25 |
| K163577 | Ecofit® Hip System | Implantcast GmbH | LZO | Class II | 2017-09-25 |
| K172628 | PRECICE System | Nuvasive Specialized Orthopedics, Inc. | HSB | Class II | 2017-09-25 |
| K170157 | INDEPENDENCE® Spacers | Globus Medical, Inc. | OVD | Class II | 2017-09-25 |
| K172086 | Matira Anterior Cervical System | Kalitec Direct, LLC | KWQ | Class II | 2017-09-22 |
| K171852 | DARCO Locking Bone Plate System | Wrightmedicaltechnologyinc | HRS | Class II | 2017-09-21 |
| K170705 | ARIX Wrist System | Jeil Medical Corporation | HRS | Class II | 2017-09-21 |
| K172501 | iNSitu Total Hip System | Theken Companies, LLC | LPH | Class II | 2017-09-21 |
| K172279 | PMT Posterior Fixation System | Providence Medical Technology, Inc. | NKG | Class II | 2017-09-20 |
| K172199 | ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium | Medtronic Sofamor Danek | MAX | Class II | 2017-09-19 |
| K171964 | LigaMetrics Suture Anchors | Mortise Medical, LLC | MBI | Class II | 2017-09-19 |
| K163422 | Shanghai Sanyou PEEK Cage System | Shanghai Sanyou Medical Co, Ltd. | ODP | Class II | 2017-09-18 |
| K172587 | Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers | Medacta International S.A. | ODP | Class II | 2017-09-18 |
| K171686 | Choice Spine Hawkeye Vertebral Body Replacement (VBR) System | Choicespine | MQP | Class II | 2017-09-15 |
| K171519 | FLXfit | Expanding Orthopedics, Inc. | MAX | Class II | 2017-09-15 |
| K172064 | Ti-Diagon Oblique TLIF | Camber Spine Technologies | MAX | Class II | 2017-09-15 |
| K171832 | Range/Denali/Mesa Spinal System | K2m, Inc. | NKB | Class II | 2017-09-14 |
| K163627 | Shotel Ankle Arthrodesis Nail System | Biopro, Inc. | HSB | Class II | 2017-09-14 |
| K163148 | BePOD® Foot Screws | Fournitures Hospitalieres Industrie | HWC | Class II | 2017-09-14 |
| K171582 | NEO Pedicle Screw System | Neo Medical SA | NKB | Class II | 2017-09-12 |
| K171067 | INVISION Total Ankle Revision System | Wrightmedicaltechnologyinc | HSN | Class II | 2017-09-11 |
| K171351 | Posterior Spine Truss System (PSTS) Interbody Fusion Device | 4Web, Inc. | MAX | Class II | 2017-09-08 |
| K163710 | BePOD® EZ Weil Screws | Fournitures Hospitalieres Industrie | HWC | Class II | 2017-09-08 |
| K172170 | APTUS(R) Wrist 2.5 System | Medartis AG | HRS | Class II | 2017-09-08 |
| K170704 | The Locking Pediatric Osteotomy Plate (LolliPOP) System | Pega Medical, Inc. | KTT | Class II | 2017-09-08 |
| K171725 | CuffLink Implant System | Conmed Corporation | MBI | Class II | 2017-09-08 |
| K171893 | Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone Synergy Cervical Interbody Fusion System (Slate) | Bluestone Synergy | MAX | Class II | 2017-09-08 |
| K171510 | Footmotion Plating System | Newclip Technics | HRS | Class II | 2017-09-08 |
| K170855 | T-Rex Standalone ALIF | Siats, LLC | OVD | Class II | 2017-09-07 |
| K172489 | Reliance Cervical IBF System | Reliance Medical Systems, LLC | ODP | Class II | 2017-09-07 |
| K162171 | S4 Screw System | Subchondral Solutions | HWC | Class II | 2017-09-07 |
| K171496 | Tritanium C Anterior Cervical Cage | Stryker Spine | ODP | Class II | 2017-09-06 |
| K171558 | ExsoMed ITN Cannulated Screw System | Exsomed Holdings Company, LLC | HWC | Class II | 2017-09-01 |
| K170547 | Arthrex Mesh Plate System | Arthrex, Inc. | HRS | Class II | 2017-09-01 |
| K171570 | Additional VIPER PRIME screws with fenestrations | Medos International SARL | NKB | Class II | 2017-08-31 |
| K171010 | Latitude EV Total Elbow Arthroplasty | Tornier, Inc. | JDB | Class II | 2017-08-31 |
| K171704 | CAPRI Corpectomy Cage System | K2m | MQP | Class II | 2017-08-31 |
| K171791 | MAGEC® System | Nuvasive Specialized Orthopedics, Incorporated | PGN | Class II | 2017-08-31 |
| K172021 | LigaPASS | Medicrea International SA | OWI | Class II | 2017-08-30 |
| K171540 | Refobacin Bone Cement R | Biomet, Inc. | LOD | Class II | 2017-08-30 |
| K171592 | CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver | Conmed Corporation | MAI | Class II | 2017-08-29 |
| K171329 | Altus Spine Titanium Interbody Fusion System | Altus Partners, LLC | MAX | Class II | 2017-08-29 |
| K172131 | 2 Hole Lateral Plating System | Life Spine, Inc. | KWQ | Class II | 2017-08-28 |
| K171567 | IRIX-A Lumbar Integrated Fusion System | X-Spine Systems, Inc. | OVD | Class II | 2017-08-28 |
| K171181 | PROCOTYL® PRIME E-CLASS XLPE Liner | Microport Orthopedics, Inc. | LZO | Class II | 2017-08-28 |
| K163441 | Locking Cage, Full XPE Cup | United Orthopedic Corporation | LZO | Class II | 2017-08-25 |
| K171465 | Stryker Self-Punching ICONIX | Stryker | MBI | Class II | 2017-08-24 |
| K172061 | PRECICE UNYTE System | Nuvasive Specialized Orthopedics, Inc. | HSB | Class II | 2017-08-24 |
| K171563 | MagnetOs Putty | Kuros Biosciences B.V | MQV | Class II | 2017-08-24 |
| K171299 | Fixone Biocomposite Anchor | Aju Pharm Co., Ltd. | MAI | Class II | 2017-08-24 |
| K171173 | OrthoPediatrics Titanium PediPlates® System | OrthoPediatrics Corp. | HRS | Class II | 2017-08-24 |
| K171249 | Entrada hip stem | Ortho Development Corporation | MEH | Class II | 2017-08-24 |
| K172262 | EVOS Small Fragment Plating System | Smith & Nephew, Inc. | HRS | Class II | 2017-08-23 |
| K172214 | Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters | G-21 S.R.L. | NDN | Class II | 2017-08-23 |
| K172104 | Ozark(tm) Cervical Plate System | K2m, Inc. | KWQ | Class II | 2017-08-23 |
| K171140 | Matrixx System | Nexxt Spine, LLC | ODP | Class II | 2017-08-22 |
| K172107 | Threshold V2 Pedicular Fixation System, Threshold Pedicular Fixation System, Fortress Pedicular Fixation System, Palisade Pedicular Fixation System | Spineology, Inc. | NKB | Class II | 2017-08-21 |
| K163375 | INFINITY OCT System | Medtronic Sofamor Danek USA, Inc. | NKG | Class II | 2017-08-21 |
| K171526 | Zenius, lliad and Kora Spinal Fixation Systems | Medyssey USA, Inc. | NKB | Class II | 2017-08-21 |
| K172194 | Connector System | Orthofix, Inc. | NKG | Class II | 2017-08-18 |
| K170782 | Medline UNITE® Snap-Off Screws | Medline Industries, Inc. | HWC | Class II | 2017-08-18 |
| K170149 | 3DMetal Tibial Cones | Medacta International S.A. | JWH | Class II | 2017-08-18 |
| K171407 | ExsoMed ArcPhix and ExsoMed ArrowPhix | Exsomed Holding Company, LLC | HWC | Class II | 2017-08-18 |
| K171660 | Duo Lumbar Interbody Fusion Device | Spineology, Inc. | MAX | Class II | 2017-08-18 |
| K172139 | Streamline OCT Occipito-Cervico-Thoracic System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | NKG | Class II | 2017-08-18 |
17,115 clearances in the Orthopedic panel. Data: openFDA.