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 |
|---|---|---|---|
| K263269 | Park's Pectus System | Tdm Co., Ltd. | 2026-10-15 |
| K261611 | TDM Large Bone Plate and Screw System | Tdm Co., Ltd. | 2026-10-02 |
| K262649 | Alians Forearm | Newclip Technics | 2026-09-28 |
| 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810136433609 | OptimalMTP® | Forma Medical, Inc. | 2026-10-16 |
| 00810136433593 | OptimalMTP® | Forma Medical, Inc. | 2026-10-16 |
| 00888118132529 | LEVEL ONE EXTREMITY | KLS-Martin L.P. | 2026-04-23 |
| 08809986482860 | CastleLoc Pectus Bar System | L&K BIOMED CO. ,LTD. | 2026-04-17 |
| 08809986482853 | CastleLoc Pectus Bar System | L&K BIOMED CO. ,LTD. | 2026-04-17 |
| 08809986482846 | CastleLoc Pectus Bar System | L&K BIOMED CO. ,LTD. | 2026-04-17 |
| 08809986482839 | CastleLoc Pectus Bar System | L&K BIOMED CO. ,LTD. | 2026-04-17 |
| 08809986482822 | CastleLoc Pectus Bar System | L&K BIOMED CO. ,LTD. | 2026-04-17 |
| 08809986482815 | CastleLoc Pectus Bar System | L&K BIOMED CO. ,LTD. | 2026-04-17 |
| 08809986482778 | CastleLoc Pectus Bar System | L&K BIOMED CO. ,LTD. | 2025-07-21 |
| 08809986482785 | CastleLoc Pectus Bar System | L&K BIOMED CO. ,LTD. | 2025-07-21 |
| 08809986482761 | CastleLoc Pectus Bar System | L&K BIOMED CO. ,LTD. | 2025-07-18 |
| 08809986482754 | CastleLoc Pectus Bar System | L&K BIOMED CO. ,LTD. | 2025-07-18 |
| 08809986482747 | CastleLoc Pectus Bar System | L&K BIOMED CO. ,LTD. | 2025-07-18 |
| 08809986482730 | CastleLoc Pectus Bar System | L&K BIOMED CO. ,LTD. | 2025-07-18 |
| 08809986482723 | CastleLoc Pectus Bar System | L&K BIOMED CO. ,LTD. | 2025-07-18 |
| 08809986482716 | CastleLoc Pectus Bar System | L&K BIOMED CO. ,LTD. | 2025-07-18 |
| 00842188101410 | SideWinder Fracture Plates | Trimed, INC. | 2016-09-07 |
| 00842188101403 | SideWinder Fracture Plates | Trimed, INC. | 2016-09-07 |
| 00842188101397 | SideWinder Fracture Plates | Trimed, INC. | 2016-09-07 |
| 00842188101380 | SideWinder Fracture Plates | Trimed, INC. | 2016-09-07 |
| 00842188101373 | SideWinder Fracture Plates | Trimed, INC. | 2016-09-07 |
| 00842188101366 | SideWinder Fracture Plates | Trimed, INC. | 2016-09-07 |
| 00842188100932 | Hook Plates | Trimed, INC. | 2016-09-07 |
| 00842188100925 | Hook Plates | Trimed, INC. | 2016-09-07 |
| 00842188100918 | Hook Plates | Trimed, INC. | 2016-09-07 |
| 00842188100901 | Hook Plates | Trimed, INC. | 2016-09-07 |
| 00842188100895 | Hook Plates | Trimed, INC. | 2016-09-07 |
| 00842188100871 | Locking Plates | Trimed, INC. | 2016-09-07 |
| 00842188100864 | Locking Plates | Trimed, INC. | 2016-09-07 |