HRS — Plate, Fixation, Bone Class II
FDA product code HRS covers "Plate, Fixation, Bone", a Class II medical device regulated under 21 CFR 888.3030. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HRS
- Device Class
- Class II
- Regulation Number
- 888.3030
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K262098 | Nvision Biomedical Technologies | EnHAnce PEEK Bunion System | Sep 18, 2026 |
| K262963 | Treace Medical Concepts | TMC Implant Fixation System | Sep 15, 2026 |
| K261647 | Pace Surgical | Tempo Plating System; Ultra Compression Screw System | Sep 3, 2026 |
| K261830 | Ortler Global Tibbi Gerecler Anonim Sirketi | FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Vario | Aug 28, 2026 |
| K262537 | Gm Dos Reis Industria E Comercio Ltda | Versalock Sterile Plating System | Aug 19, 2026 |
| K260277 | Mikron Makina San. Ve Tic. Ltd. Sti | MIKRON TRAUMA BONE PLATE& SCREW SYSTEM | Aug 13, 2026 |
| K261511 | Newclip Technics | Xpert Ankle | Jul 28, 2026 |
| K261406 | Gm Dos Reis Industria E Comercio Ltda | Versalock Proximal Tibial Plating System | Jul 21, 2026 |
| K262032 | Trimed | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fus | Jul 16, 2026 |
| K261191 | Newclip Technics | Alians Elbow S | Jul 8, 2026 |
| K261054 | Stryker Leibinger Gmbh And Co Kg | RibPlate System | Jul 1, 2026 |
| K261351 | Bonebridge | SALGINA 2.5mm Distal Radius System | Jun 26, 2026 |
| K260958 | I.T.S | I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with An | Jun 16, 2026 |
| K261207 | Tyber Medical | Exalta Proximal Tibia Plating System | Jun 12, 2026 |
| K260761 | Medartis | APTUS Clavicle System 2.8 | Jun 5, 2026 |
| K261002 | Biomet Microfixation | Pectus Blu System | Jun 2, 2026 |
| K261038 | Newclip Technics | Xpert PFP | May 29, 2026 |
| K261145 | Avanti Orthopaedics | Avanti Distal Elbow ORIF System | May 9, 2026 |
| K260323 | Orthopediatrics | OrthoPediatrics® Locking Cannulated Blade Plate System | Apr 30, 2026 |
| K260228 | Bonebridge | POYA 3.5mm Medial Proximal Tibia System | Apr 24, 2026 |