Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 30
- Latest Decision
- 2017-06-13
Clearances · page 46 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K171468 | FUSE Spinal System | Medtronic Sofamor Danek | MAX | Class II | 2017-06-13 |
| K162986 | SPIRA Open Matrix ALIF | Camber Spine Technologies | MAX | Class II | 2017-06-12 |
| K171509 | Iliad® Pedicle Screw System and Zenius® Pedicle Screw System | Medyssey USA, Inc. | NKB | Class II | 2017-06-12 |
| K162685 | 2-Piece Hammertoe Correction System | Life Spine, Inc. | HWC | Class II | 2017-06-09 |
| K170169 | PRECICE Intramedullary Limb Lengthening System | Nuvasive Specialized Orthopedics, Inc. | HSB | Class II | 2017-06-09 |
| K170730 | JAZZ System, including JAZZ Band | Implanet, S.A. | OWI | Class II | 2017-06-09 |
| K163193 | UTF Stem, reduced, #0, #00 | United Orthopedic Corporation | LPH | Class II | 2017-06-08 |
| K171112 | Trifore(tm) Cervical Plating System | Neurostructures, Inc. | KWQ | Class II | 2017-06-08 |
| K170961 | NuVasive CoRoent Small Interlock II System | Nu Vasive, Incorporated | OVE | Class II | 2017-06-08 |
| K162996 | INVISIKNOT Ankle Syndesmosis Repair Kit | Smith & Nephew, Inc. | HTN | Class II | 2017-06-08 |
| K170821 | ChoiceSpine Proliant® Posterior Pedicle Screw and Hook Fixation System | Choicespine, LP | NKB | Class II | 2017-06-08 |
| K161327 | SYNTEC HUMERAL NAIL SYSTEM | Syntec Scientific Corporation | HSB | Class II | 2017-06-08 |
| K170687 | Flower Bone Screw Set | Flower Orthopedics Corporation | HWC | Class II | 2017-06-06 |
| K171438 | Palisade Pedicular Fixation System | Spineology, Inc. | NKB | Class II | 2017-06-02 |
| K171060 | OrthoButton AL | Riverpoint Medical | MBI | Class II | 2017-06-02 |
| K170877 | Parcus SLiK Fix Screw | Parcus Medical | MBI | Class II | 2017-06-02 |
| K170395 | Talos® Lumbar (HA) PEEK IBF Devices | Meditech Spine, LLC | MAX | Class II | 2017-06-02 |
| K170890 | TELIX K Interbody System | Biedermann Motech GmbH & Co. KG | MAX | Class II | 2017-06-02 |
| K163585 | Responsive Orthopedics Total Hip Arthroplasty System | Responsive Orthopedics, LLC | LZO | Class II | 2017-06-02 |
| K162682 | MATISSE Anterior Cervical Interbody Fusion Cage System | Ctl Medical Corporation | ODP | Class II | 2017-06-01 |
| K170711 | ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System | Zimmer GmbH | PHX | Class II | 2017-06-01 |
| K170573 | Empowr CR Knee Tibial Insert | Encore Medical L.P. | JWH | Class II | 2017-05-31 |
| K170698 | ALLY(TM) Bone Screws | Providence Medical Technology, Inc. | HWC | Class II | 2017-05-31 |
| K170611 | SETx Pedicle Screw System | Xenco Medical, LLC | NKB | Class II | 2017-05-25 |
| K171170 | M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws | Medacta International S.A. | NKB | Class II | 2017-05-25 |
| K170306 | FIBERGRAFT BG Putty Bone Graft Substitute | Prosidyan, Inc. | MQV | Class II | 2017-05-24 |
| K163673 | Fortilink-C with TETRAfuse 3D Technology | Rti Surgical, Inc. | ODP | Class II | 2017-05-23 |
| K170989 | Dymaxeon Spine System | Back 2 Basics Direct, LLC | NKB | Class II | 2017-05-22 |
| K170021 | SMV Scientific Cannulated Screws | Smv Scientific | HWC | Class II | 2017-05-22 |
| K170282 | Smith & Nephew VISIONAIRE Adaptive Guides | Smith & Nephew, Inc. | JWH | Class II | 2017-05-22 |
| K163610 | PIEZOTOME M+, PIEZOTOME M+ Handpiece | Satalec-Acteon Group | JDX | Class II | 2017-05-19 |
| K162212 | DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM | Medtronic Sofamor Danek USA, Inc. | MAX | Class II | 2017-05-19 |
| K170639 | HEALIX ADVANCE Anchor with PERMATAPE Suture | Medos International SARL | MAI | Class II | 2017-05-18 |
| K170804 | The Solstice OCT System | Life Spine, Inc. | NKG | Class II | 2017-05-18 |
| K163669 | Humeris Shoulder | Fx Solutions | PHX | Class II | 2017-05-17 |
| K171020 | Arthrex Knotless SutureTak Anchor | Arthrex, Inc. | MBI | Class II | 2017-05-16 |
| K163226 | EPIC Extremely Small Staple | Epic Extremely, LLC | JDR | Class II | 2017-05-16 |
| K163181 | TRANSLACE Spinal Tethering System | Medtronic Sofamor Danek USA, Inc. | OWI | Class II | 2017-05-16 |
| K171327 | Tyber Medical Wedge System | Tyber Medical, LLC | PLF | Class II | 2017-05-16 |
| K170496 | Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory | Stryker Corporation | NKB | Class II | 2017-05-16 |
| K162133 | VerteFIT Corpectomy Cage System | Ldr Spine USA, Inc. | MQP | Class II | 2017-05-16 |
| K170401 | Piccolo Composite® Plate System | CarboFix Orthopedics , Ltd. | HRS | Class II | 2017-05-12 |
| K170382 | Arthrex Compression Screws | Arthrex, Inc. | HWC | Class II | 2017-05-11 |
| K170679 | CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems | Medtronic Sofamor Danek | NKB | Class II | 2017-05-11 |
| K170648 | ANTHEM CR Total Knee System | Smith & Nephew, Inc. | JWH | Class II | 2017-05-11 |
| K170647 | Connector System | Orthofix, Inc. | NKG | Class II | 2017-05-11 |
| K170594 | I.B.S. osteosynthesis screws | In2bones Sas | HWC | Class II | 2017-05-10 |
| K162125 | MALUC Total Hip Arthroplasty System | Surgtech, Inc. | JDI | Class II | 2017-05-10 |
| K171097 | MOJAVE Expandable Interbody System | K2m, Inc. | MAX | Class II | 2017-05-10 |
| K170650 | Orthofix TrueLok Hexapod System (TL-HEX) V2.0 | Orthofix Srl | KTT | Class II | 2017-05-10 |
| K170342 | Ocata Anterior Cervical System | Kalitec Direct, LLC | KWQ | Class II | 2017-05-09 |
| K163670 | Rampart One Lumbar Interbody Fusion Device | Spineology, Inc. | OVD | Class II | 2017-05-08 |
| K163327 | Precifit Medical Kirschner Wires | Precifit Medical, Ltd. | HTY | Class II | 2017-05-08 |
| K170771 | VariAx 2 Foot System | Stryker GmbH | HRS | Class II | 2017-05-08 |
| K170475 | SICAGE System | Sicage, LLC | OUR | Class II | 2017-05-05 |
| K163293 | Colink Plating System | In2bones USA, LLC | HRS | Class II | 2017-05-05 |
| K163672 | Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor | Nanova Biomaterials, Inc. | MAI | Class II | 2017-05-05 |
| K171082 | Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spinal Fixation System, Firebird NXG Spinal Fixation System | Orthofix, Inc. | NKB | Class II | 2017-05-05 |
| K162496 | Foundation 3D Interbody | Corelink, LLC | ODP | Class II | 2017-05-04 |
| K170543 | VIPER PRIME Screws with Fenestrations | Medos International SARL | NKB | Class II | 2017-05-04 |
| K171141 | Arthrex SwiveLock Anchors | Arthrex, Inc. | MAI | Class II | 2017-05-04 |
| K170440 | KISSloc Suture System | Arthrosurface, Inc. | HTN | Class II | 2017-05-03 |
| K163481 | HALF DOME Posterior Lumbar Interbody System | Astura Medical | MAX | Class II | 2017-05-03 |
| K162380 | Locking Plate System | Beijing Keyi Medical Device Technology Co., Ltd. | HRS | Class II | 2017-05-02 |
| K170108 | Xultan 5.5 Pedicle Screw System | Met One Technologies | NKB | Class II | 2017-05-02 |
| K163621 | Vitoss Bioactive (BA) Injectable | Orthovita, Inc. | MQV | Class II | 2017-05-02 |
| K163707 | NuVasive CoRoent Ti-C System | Nu Vasive, Incorporated | MAX | Class II | 2017-05-01 |
| K162303 | REDAPT Sleeved Monolithic Revision Stems | Smith & Nephew, Inc. | MEH | Class II | 2017-05-01 |
| K162825 | CAPTIVATE Compression Screws | Globus Medical, Inc. | HWC | Class II | 2017-05-01 |
| K162266 | The Cranial Fusion System | Life Spine, Inc. | NKG | Class II | 2017-05-01 |
| K171045 | Exactech® Truliant Line Extensions | Exactech, Inc. | JWH | Class II | 2017-04-28 |
| K170964 | Zenius Spinal System | Medyssey USA, Inc. | NKB | Class II | 2017-04-26 |
| K170572 | Summit Spine Yellowstone Lumbar Interbody Fusion System | Summit Spine | MAX | Class II | 2017-04-26 |
| K170592 | NuVasive BASE Interfixated Titanium System | Nu Vasive, Incorporated | OVD | Class II | 2017-04-26 |
| K170889 | HV Screw System | Wrightmedicaltechnologyinc | HWC | Class II | 2017-04-26 |
| K162732 | Exactech® Alteon® HA Femoral Stem | Exactech, Inc. | MEH | Class II | 2017-04-26 |
| K170942 | The Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems | Choicespine, LP | NKB | Class II | 2017-04-26 |
| K163332 | Apex Revision Knee System | Omnilife Science | JWH | Class II | 2017-04-26 |
| K170511 | NeoFuse HA Enhanced PLIF/TLIF | Ht Medical, LLC | MAX | Class II | 2017-04-25 |
| K170012 | Foot and Hand Motion | Newclip Technics | HWC | Class II | 2017-04-24 |
| K162154 | Pantheon Medical Balanced Plating System | Pantheon Medical | HRS | Class II | 2017-04-24 |
| K163650 | ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension | Wrightmedicaltechnologyinc | HRS | Class II | 2017-04-24 |
| K170887 | EVOS Small Fragment Plating System | Smith & Nephew, Inc. | HRS | Class II | 2017-04-24 |
| K170953 | Tomcat Cervical Spinal System | Choicespine, LP | OVE | Class II | 2017-04-21 |
| K162236 | Ax Stand-Alone ALIF System | Innovasis, Inc. | OVD | Class II | 2017-04-20 |
| K162354 | Sniper Staple System | Trilliant Surgical, Ltd. | JDR | Class II | 2017-04-20 |
| K163383 | GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND Of DHS/Dynamic Condylar Plate Plating System | Greens Surgicals Pvt. , Ltd. | HRS | Class II | 2017-04-19 |
| K162087 | NovoGro | Osteonovus, Inc. | MQV | Class II | 2017-04-18 |
| K161741 | GMK UNI | Medacta International S.A. | HSX | Class II | 2017-04-14 |
| K170643 | Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System | Rti Surgical, Inc. Dba Rti Biologics | MAX | Class II | 2017-04-14 |
| K170255 | Threshold V2 Pedicular Fixation System | Spineology, Inc. | NKB | Class II | 2017-04-14 |
| K170268 | Fortress Pedicular Fixation System | Spineology, Inc. | NKB | Class II | 2017-04-14 |
| K170266 | Palisade Pedicular Fixation System | Spineology, Inc. | NKB | Class II | 2017-04-14 |
| K163656 | Hoffmann LRF System | Stryker GmbH | KTT | Class II | 2017-04-14 |
| K170251 | Threshold Pedicular Fixation System | Spineology, Inc. | NKB | Class II | 2017-04-14 |
| K170214 | Additive Orthopaedics Locking Lattice Plate | Additive Orthopaedics, LLC | HRS | Class II | 2017-04-13 |
| K163269 | Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic Interbody Fusion Device | Titan Spine, LLC | OVD | Class II | 2017-04-13 |
| K162353 | MICATM Screw System | Wrightmedicaltechnologyinc | HWC | Class II | 2017-04-13 |
| K170055 | CAPRI Corpectomy Cage System | K2m | MQP | Class II | 2017-04-13 |
| K161114 | HIGH V+ | Teknimed Sas | NDN | Class II | 2017-04-12 |
17,115 clearances in the Orthopedic panel. Data: openFDA.