Product code HRS
- Device name
- Plate, Fixation, Bone
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3030
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261892 | ProRib Fixation System | Costa Surgical, Inc. | 2026-09-23 |
| K262098 | EnHAnce PEEK Bunion System | Nvision Biomedical Technologies | 2026-09-18 |
| K262963 | TMC Implant Fixation System | Treace Medical Concepts, Inc. | 2026-09-15 |
| K261647 | Tempo Plating System; Ultra Compression Screw System | Pace Surgical | 2026-09-03 |
| K261830 | FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog) | Ortler Global Tibbi Gerecler Anonim Sirketi | 2026-08-28 |
| K262537 | Versalock Sterile Plating System | GM Dos Reis Industria e Comercio Ltda. | 2026-08-19 |
| K260277 | MIKRON TRAUMA BONE PLATE& SCREW SYSTEM | Mikron Makina San. ve Tic. Ltd. Sti. | 2026-08-13 |
| K261511 | Xpert Ankle | Newclip Technics | 2026-07-28 |
| K261406 | Versalock Proximal Tibial Plating System | GM Dos Reis Industria e Comercio Ltda. | 2026-07-21 |
| K262032 | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB ) | TriMed, Inc. | 2026-07-16 |
| K261191 | Alians Elbow S | Newclip Technics | 2026-07-08 |
| K261054 | RibPlate System | Stryker Leibinger GmbH & Co KG | 2026-07-01 |
| K261351 | SALGINA 2.5mm Distal Radius System | Bonebridge AG | 2026-06-26 |
| K260958 | I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. O... | I.T.S. GmbH | 2026-06-16 |
| K261207 | Exalta Proximal Tibia Plating System | Tyber Medical, LLC | 2026-06-12 |
| K260761 | APTUS Clavicle System 2.8 | Medartis AG | 2026-06-05 |
| K261002 | Pectus Blu System | Biomet Microfixation | 2026-06-02 |
| K261038 | Xpert PFP | Newclip Technics | 2026-05-29 |
| K261145 | Avanti Distal Elbow ORIF System | Avanti Orthopaedics, LLC | 2026-05-09 |
| K260323 | OrthoPediatrics® Locking Cannulated Blade Plate System | OrthoPediatrics Corp. | 2026-04-30 |
| K260054 | I.T.S. PRS Phoenix II | I.T.S. GmbH | 2026-04-24 |
| K260228 | POYA 3.5mm Medial Proximal Tibia System | Bonebridge AG | 2026-04-24 |
| K260411 | PC Fix System | Chest Wall Innovations, Inc. | 2026-04-24 |
| K260090 | SMART Osteotomy System | Actis Medical Pty., Ltd. | 2026-04-10 |
| K253718 | enHAnce PEEK Bunion System | Nvision Biomedical Technologies, Inc. | 2026-04-01 |
| K260274 | Airlock® Ankle Plating System | Novastep SAS | 2026-03-25 |
| K260291 | Vortex5 Tailor's Bunion Correction System | Nvision Biomedical Technologies, Inc. | 2026-03-25 |
| K254253 | LOQTEQ® VA Proximal Humerus Plate 3.5 | Aap Implantate AG | 2026-03-24 |
| K254288 | Clavicle Fixation System | Skeletal Dynamics, Inc. | 2026-03-23 |
| K260448 | CastleLoc Pectus Bar System | L&K BIOMED Co., Ltd. | 2026-03-19 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10886982350732 | VOLT | Synthes GmbH | 2026-09-25 |
| 10886982350879 | VOLT | Synthes GmbH | 2026-09-25 |
| 10886982350862 | VOLT | Synthes GmbH | 2026-09-25 |
| 10886982350855 | VOLT | Synthes GmbH | 2026-09-25 |
| 10886982350848 | VOLT | Synthes GmbH | 2026-09-25 |
| 10886982350831 | VOLT | Synthes GmbH | 2026-09-25 |
| 10886982350824 | VOLT | Synthes GmbH | 2026-09-25 |
| 10886982350817 | VOLT | Synthes GmbH | 2026-09-25 |
| 10886982350800 | VOLT | Synthes GmbH | 2026-09-25 |
| 10886982350794 | VOLT | Synthes GmbH | 2026-09-25 |
| 10886982350787 | VOLT | Synthes GmbH | 2026-09-25 |
| 10886982350770 | VOLT | Synthes GmbH | 2026-09-25 |
| 10886982350763 | VOLT | Synthes GmbH | 2026-09-25 |
| 10886982350756 | VOLT | Synthes GmbH | 2026-09-25 |
| 10886982350749 | VOLT | Synthes GmbH | 2026-09-25 |
| 00889095401820 | ANTHEM | GLOBUS MEDICAL, INC. | 2026-09-25 |
| 00889095611274 | ANTHEM | GLOBUS MEDICAL, INC. | 2026-09-25 |
| 00889095411324 | ANTHEM | GLOBUS MEDICAL, INC. | 2026-09-25 |
| 00889095411300 | ANTHEM | GLOBUS MEDICAL, INC. | 2026-09-25 |
| 00889095411287 | ANTHEM | GLOBUS MEDICAL, INC. | 2026-09-25 |
| 00889095411263 | ANTHEM | GLOBUS MEDICAL, INC. | 2026-09-25 |
| 00889095402537 | ANTHEM | GLOBUS MEDICAL, INC. | 2026-09-25 |
| 00889095402483 | ANTHEM | GLOBUS MEDICAL, INC. | 2026-09-25 |
| 00889095402438 | ANTHEM | GLOBUS MEDICAL, INC. | 2026-09-25 |
| 00889095402285 | ANTHEM | GLOBUS MEDICAL, INC. | 2026-09-25 |
| 00889095401929 | ANTHEM | GLOBUS MEDICAL, INC. | 2026-09-25 |
| 00889095401905 | ANTHEM | GLOBUS MEDICAL, INC. | 2026-09-25 |
| 00889095401882 | ANTHEM | GLOBUS MEDICAL, INC. | 2026-09-25 |
| 00889095401868 | ANTHEM | GLOBUS MEDICAL, INC. | 2026-09-25 |
| 00889095401844 | ANTHEM | GLOBUS MEDICAL, INC. | 2026-09-25 |