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 |
|---|---|---|---|
| K262032 | trimed | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fus | July 16, 2026 |
| K261191 | newclip technics | Alians Elbow S | July 8, 2026 |
| K261054 | stryker leibinger gmbh and co kg | RibPlate System | July 1, 2026 |
| K261351 | bonebridge | SALGINA 2.5mm Distal Radius System | June 26, 2026 |
| 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 |