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 |
|---|---|---|---|
| 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 |
| K254053 | APS Spear Locking Plate | A Plus Biotechnology Co., Ltd. | 2026-03-17 |
| K260390 | Super Upper Limbs Versalock Plating System | GM Dos Reis Industria e Comercio Ltda. | 2026-03-17 |
| K253916 | APTUS Shoulder Proximal Humerus System, PentaLock 3.5 | Medartis AG | 2026-03-16 |
| K253906 | Xpert Hand | Newclip Technics | 2026-03-11 |
| K254093 | DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System | Synthes GmbH | 2026-03-10 |
| K260069 | DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System | Synthes GmbH | 2026-03-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00842188132452 | Tools - TWF | Trimed, INC. | 2026-08-18 |
| 00842188132445 | Tools - TWF | Trimed, INC. | 2026-08-17 |
| 00842188132261 | Non-Spanning Wrist Fusion | Trimed, INC. | 2026-08-17 |
| 00842188132254 | Non-Spanning Wrist Fusion | Trimed, INC. | 2026-08-17 |
| 00842188132247 | Non-Spanning Wrist Fusion | Trimed, INC. | 2026-08-17 |
| 00842188132230 | Non-Spanning Wrist Fusion | Trimed, INC. | 2026-08-17 |
| 00193982158323 | ANTHEM | GLOBUS MEDICAL, INC. | 2026-08-14 |
| 00193982101947 | ANTHEM | GLOBUS MEDICAL, INC. | 2026-08-14 |
| 00193982101923 | ANTHEM | GLOBUS MEDICAL, INC. | 2026-08-14 |
| 00193982101909 | ANTHEM | GLOBUS MEDICAL, INC. | 2026-08-14 |
| 00193982096311 | ANTHEM | GLOBUS MEDICAL, INC. | 2026-08-14 |
| 00193982096298 | ANTHEM | GLOBUS MEDICAL, INC. | 2026-08-14 |
| 00193982096274 | ANTHEM | GLOBUS MEDICAL, INC. | 2026-08-14 |
| 00842188127014 | Tools - FMS | Trimed, INC. | 2023-04-19 |
| 00842188114830 | Hook Plates | Trimed, INC. | 2016-09-29 |
| 00842188100437 | Foot Plates | Trimed, INC. | 2016-09-07 |
| 00842188111273 | Tools - FMS | Trimed, INC. | 2016-09-07 |
| 00842188111266 | Tools - FMS | Trimed, INC. | 2016-09-07 |
| 00842188111259 | Tools - FMS | Trimed, INC. | 2016-09-07 |
| 00842188101533 | Osteotomy Compression Plates | Trimed, INC. | 2016-09-07 |
| 00842188101526 | Osteotomy Compression Plates | Trimed, INC. | 2016-09-07 |
| 00842188100956 | Hook Plates | Trimed, INC. | 2016-09-07 |
| 00842188100949 | Hook Plates | Trimed, INC. | 2016-09-07 |
| 00842188100888 | Locking Plates | Trimed, INC. | 2016-09-07 |
| 00842188100482 | Foot Plates | Trimed, INC. | 2016-09-07 |
| 00842188100475 | Foot Plates | Trimed, INC. | 2016-09-07 |
| 00842188100468 | Foot Plates | Trimed, INC. | 2016-09-07 |
| 00842188100451 | Foot Plates | Trimed, INC. | 2016-09-07 |
| 00842188100444 | Foot Plates | Trimed, INC. | 2016-09-07 |
| 24026704515800 | PILLING | TELEFLEX INCORPORATED | 2015-10-16 |