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 |
|---|
| K260958 | i.t.s | I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with An | June 16, 2026 |
| K261207 | tyber medical | Exalta Proximal Tibia Plating System | June 12, 2026 |
| K260761 | medartis | APTUS Clavicle System 2.8 | June 5, 2026 |
| K261002 | biomet microfixation | Pectus Blu System | June 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 | April 30, 2026 |
| K260228 | bonebridge | POYA 3.5mm Medial Proximal Tibia System | April 24, 2026 |
| K260411 | chest wall innovations | PC Fix System | April 24, 2026 |
| K260054 | i.t.s | I.T.S. PRS Phoenix II | April 24, 2026 |
| 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 |