Jacksonville, FL, US · 8 510(k) clearances · 2 PMAs
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| HRS | Plate, Fixation, Bone | Class II | Orthopedic | 5 | 2026-06-02 |
| HBE | — | — | — | 2 | 2022-11-15 |
| JEY | Plate, Bone | Class II | Dental | 1 | 2021-08-05 |
| Date | PMA # | Trade name | Type | Code | Device name | Specialty |
|---|---|---|---|---|---|---|
| 2026-07-27 | P020016-S010 | Total Temporomandibular Joint Replacement System | Normal 180 Day Track No User Fee | — | — | — |
| 2026-02-19 | P020016-S013 | Total Temporomandibular Joint Replacement System | 30-Day Notice | LZD | — | — |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-06-02 | K261002 | Pectus Blu System | HRS | Class II | Orthopedic |
| 2024-09-19 | K241709 | Pectus Blu Support Bar System | HRS | Class II | Orthopedic |
| 2022-11-15 | K223199 | 2.1 x 255mm Drill, 22mm Stop | HBE | — | — |
| 2022-05-17 | K212782 | SternaLock Sternal Closure System | HRS | Class II | Orthopedic |
| 2022-04-22 | K212608 | RibFix Blu Thoracic Fixation System | HRS | Class II | Orthopedic |
| 2022-03-11 | K213712 | Pectus Support Bar System | HRS | Class II | Orthopedic |
| 2021-12-23 | K213208 | Twist Drills | HBE | — | — |
| 2021-08-05 | K202969 | Biomet Microfixation OmniMax MMF System | JEY | Class II | Dental |