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 |
|---|---|---|---|
| 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 |
| 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00190446951971 | Arsenal Foot | Trilliant Surgical, LLC | 2026-06-24 |
| 00190446952350 | Arsenal Foot | Trilliant Surgical, LLC | 2026-06-24 |
| 00190446952343 | Arsenal Foot | Trilliant Surgical, LLC | 2026-06-24 |
| 00190446952336 | Arsenal Foot | Trilliant Surgical, LLC | 2026-06-24 |
| 00190446952060 | Arsenal Foot | Trilliant Surgical, LLC | 2026-06-24 |
| 00190446952046 | Arsenal Foot | Trilliant Surgical, LLC | 2026-06-24 |
| 00190446952039 | Arsenal Foot | Trilliant Surgical, LLC | 2026-06-24 |
| 00190446952022 | Arsenal Foot | Trilliant Surgical, LLC | 2026-06-24 |
| 00190446952015 | Arsenal Foot | Trilliant Surgical, LLC | 2026-06-24 |
| 00190446951995 | Arsenal Foot | Trilliant Surgical, LLC | 2026-06-24 |
| 00190446951988 | Arsenal Foot | Trilliant Surgical, LLC | 2026-06-24 |
| 00190446951964 | Arsenal Foot | Trilliant Surgical, LLC | 2026-06-24 |
| 00190446950219 | Arsenal Foot | Trilliant Surgical, LLC | 2026-06-24 |
| 00190446950202 | Arsenal Foot | Trilliant Surgical, LLC | 2026-06-24 |
| 00190446950196 | Arsenal Foot | Trilliant Surgical, LLC | 2026-06-24 |
| 00190446950189 | Arsenal Foot | Trilliant Surgical, LLC | 2026-06-24 |
| 00190446950172 | Arsenal Foot | Trilliant Surgical, LLC | 2026-06-24 |
| 00190446950110 | Arsenal Foot | Trilliant Surgical, LLC | 2026-06-24 |
| 00190446952367 | Arsenal Foot | Trilliant Surgical, LLC | 2026-06-24 |
| B56211113940014S10 | PRIMA Proximal Femur Locking Plate System | Wishbone Medical, Inc. | 2023-04-12 |
| B562PKPF350000 | PRIMA Proximal Femur Locking Plate System | Wishbone Medical, Inc. | 2023-04-12 |
| B56211114381800S10 | PRIMA Proximal Femur Locking Plate System | Wishbone Medical, Inc. | 2023-04-12 |
| B56211114930006S10 | PRIMA Proximal Femur Locking Plate System | Wishbone Medical, Inc. | 2023-04-12 |
| B56211113940006S10 | PRIMA Proximal Femur Locking Plate System | Wishbone Medical, Inc. | 2023-04-12 |
| B562PKDF350000 | PRIMA Femoral Locking Plate System | Wishbone Medical, Inc. | 2023-04-06 |
| B562PKDF450000 | PRIMA Femoral Locking Plate System | Wishbone Medical, Inc. | 2023-04-06 |
| 00888867237612 | Arthrex® | ARTHREX, INC. | 2017-05-11 |
| 00888867179493 | Arthrex® | ARTHREX, INC. | 2017-04-07 |
| 00888867186293 | Arthrex® | ARTHREX, INC. | 2017-03-03 |
| 10886982113078 | NA | Synthes GmbH | 2016-03-15 |