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 |
|---|
| K260090 | actis medical pty | SMART Osteotomy System | April 10, 2026 |
| K253718 | nvision biomedical technologies | enHAnce PEEK Bunion System | April 1, 2026 |
| K260274 | novastep | Airlock® Ankle Plating System | March 25, 2026 |
| K260291 | nvision biomedical technologies | Vortex5 Tailor's Bunion Correction System | March 25, 2026 |
| K254253 | aap implantate | LOQTEQ® VA Proximal Humerus Plate 3.5 | March 24, 2026 |
| K254288 | skeletal dynamics | Clavicle Fixation System | March 23, 2026 |
| K260448 | l and k biomed co | CastleLoc Pectus Bar System | March 19, 2026 |
| K260390 | gm dos reis industria e comercio ltda | Super Upper Limbs Versalock Plating System | March 17, 2026 |
| K254053 | a plus biotechnology co | APS Spear Locking Plate | March 17, 2026 |
| K253916 | medartis | APTUS Shoulder Proximal Humerus System, PentaLock 3.5 | March 16, 2026 |
| 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 |
| K254162 | kls martin l.p | KLS Martin Ixos 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 |