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 |
|---|---|---|---|
| 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 |
| K260411 | PC Fix System | Chest Wall Innovations, Inc. | 2026-04-24 |
| K260228 | POYA 3.5mm Medial Proximal Tibia System | Bonebridge AG | 2026-04-24 |
| K260054 | I.T.S. PRS Phoenix II | I.T.S. GmbH | 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 |
| K260291 | Vortex5 Tailor's Bunion Correction System | Nvision Biomedical Technologies, Inc. | 2026-03-25 |
| K260274 | Airlock® Ankle Plating System | Novastep SAS | 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 |
| K260390 | Super Upper Limbs Versalock Plating System | GM Dos Reis Industria e Comercio Ltda. | 2026-03-17 |
| K254053 | APS Spear Locking Plate | A Plus Biotechnology Co., Ltd. | 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 |
| K260069 | DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System | Synthes GmbH | 2026-03-09 |
| K260353 | Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button | Arthrex, Inc. | 2026-03-03 |
| K254054 | VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System | Synthes GmbH | 2026-03-02 |
| K254249 | HKT Anatomical Locking Trauma System | Hankil Tech Medical Co., Ltd. | 2026-02-27 |
| K252166 | RIB LINK™ Fixation System | Globus Medical, Inc. | 2026-02-26 |
| K254162 | KLS Martin Ixos System | KLS Martin L.P. | 2026-02-20 |
| K253660 | KLS Martin Pure Pectus System | KLS-Martin L.P. | 2026-02-20 |
| K251732 | Wrist Fracture System | Met One Technologies, LLC | 2026-02-12 |
| K253713 | Arthrex Variable Angle (VA) Proximal Tibia Plating System | Arthrex, Inc. | 2026-01-21 |
| K254002 | TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13-7S); TriMed Volar Bearing Plates (VBEAL-14-7S); TriMed Volar Bearing Plates (VBEAR-14-7S); TriMed Volar Bearing Plates (VBEAL-16-7S); TriMed Volar Bearing P... | TriMed, Inc. | 2026-01-15 |
| K252807 | Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates | Arthrex, Inc. | 2026-01-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00840536800046 | 3P Hip System | ORTHOPEDIATRICS CORP. | 2026-06-09 |
| 00840536800053 | 3P Hip System | ORTHOPEDIATRICS CORP. | 2026-06-09 |
| 00840536800060 | 3P Hip System | ORTHOPEDIATRICS CORP. | 2026-06-09 |
| 00840536800039 | 3P Hip System | ORTHOPEDIATRICS CORP. | 2026-06-09 |
| 10886982162236 | LCP | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982164322 | NA | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982162250 | LCP | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982164124 | NA | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982164148 | NA | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982164162 | NA | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982164186 | NA | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982164209 | NA | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982164223 | NA | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982164247 | NA | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982164261 | NA | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982164285 | NA | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982164308 | NA | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982162212 | LCP | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982162199 | LCP | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982162175 | LCP | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982162151 | LCP | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982162137 | LCP | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982162113 | LCP | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982162090 | LCP | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982162076 | LCP | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982162052 | LCP | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982162038 | LCP | SYNTHES (U.S.A.) LP | 2015-09-14 |
| 10886982042590 | LCP | Synthes GmbH | 2015-09-14 |
| 10886982033079 | VA-LCP | Synthes GmbH | 2015-09-14 |
| 10886982030054 | LCP | Synthes GmbH | 2015-09-14 |