HRS — Plate, Fixation, Bone Class II
FDA Device Classification
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 |
|---|
| K253906 | newclip technics | Xpert Hand | March 11, 2026 |
| K260069 | synthes | DePuy Synthes VOLT Proximal Tibia 3.5 Plating System | March 9, 2026 |
| K260353 | arthrex | Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button | March 3, 2026 |
| K254054 | synthes | VOLT Ankle Trauma 2.7/3.5 Plating System; VOLT Calcaneus 2.7 Plating System | March 2, 2026 |
| K254249 | hankil tech medical co | HKT Anatomical Locking Trauma System | February 27, 2026 |
| K252166 | globus medical | RIB LINK Fixation System | February 26, 2026 |
| K253660 | kls-martin l.p | KLS Martin Pure Pectus System | February 20, 2026 |
| K251732 | met one technologies | Wrist Fracture System | February 12, 2026 |
| K253713 | arthrex | Arthrex Variable Angle (VA) Proximal Tibia Plating System | January 21, 2026 |
| K254002 | trimed | TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13 | January 15, 2026 |
| K252807 | arthrex | Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates | January 12, 2026 |
| K253178 | crossroads extremity systems | TRILEAP Plating System | January 6, 2026 |
| K251050 | gm dos reis industria e comercio | Pectus Versa System | December 19, 2025 |
| K252191 | bonebridge | BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System | December 17, 2025 |
| K252897 | a plus biotechnology co | APS Osteotomy Fixation System (0945-1302-xx /4.5mm Cortex Screw); APS Osteotomy | December 11, 2025 |
| K250988 | kls-martin l.p | KLS Martin Pure Pectus System | December 11, 2025 |
| K252997 | hyperflex medical | HyperFlex® Bunion Correction System | December 11, 2025 |
| K252661 | fusion innovations | SternaFuse Ti Fixation System | November 19, 2025 |
| K253423 | nvision biomedical technologies | ToeJack MIS Bunion System | November 18, 2025 |
| K250865 | kls-martin l.p | KLS Martin IPS Forearm System | November 14, 2025 |