Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K121302
BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM · Biomet Microfixation · decided 2012-09-19 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| STERNALOCK BLU SYSTEM | SP-3037 | BIOMET MICROFIXATION, INC | HRS | 00841036169848 |
| STERNALOCK® SYSTEM | SP-2374 | BIOMET MICROFIXATION, INC | HRS | 00841036138424 |
| STERNALOCK(TM) SYSTEM 5/PK | 75-6416 | BIOMET MICROFIXATION, INC | HRS | 00841036122867 |
| STERNALOCK BLU SYSTEM | SP-3245 | BIOMET MICROFIXATION, INC | HRS | 00841036196059 |
| STERNALOCK® BLU SYSTEM | 73-1952 | BIOMET MICROFIXATION, INC | HRS | 00888233000857 |
| STERNALOCK BLU SYSTEM | SP-3142 | BIOMET MICROFIXATION, INC | HRS | 00841036177072 |
| STERNALOCK® BLU SYSTEM | 73-2418 | BIOMET MICROFIXATION, INC | HRS | 00888233000918 |
| STERNALOCK® BLU SYSTEM | SP-2933 | BIOMET MICROFIXATION, INC | HRS | 00888233020602 |
| STERNALOCK® BLU SYSTEM | 73-2712 | BIOMET MICROFIXATION, INC | HRS | 00841036143435 |
| (unnamed) | SP-3139 | BIOMET MICROFIXATION, INC | HRS | 00888233022385 |
| STERNALOCK® BLU SYSTEM | 73-2412 | BIOMET MICROFIXATION, INC | HRS | 00888233000888 |
| STERNALOCK® SYSTEM | 71-2632 | BIOMET MICROFIXATION, INC | HRS | 00841036123109 |
| STERNALOCK® BLU SYSTEM | SP-3037 | BIOMET MICROFIXATION, INC | HRS | 00888233021548 |
| STERNALOCK® BLU SYSTEM | 73-2420 | BIOMET MICROFIXATION, INC | HRS | 00888233000925 |
| STERNALOCK® BLU SYSTEM | SP-3041 | BIOMET MICROFIXATION, INC | HRS | 00841036168933 |
| STERNALOCK® BLU SYSTEM | SP-3001 | BIOMET MICROFIXATION, INC | HRS | 00841036164034 |
| STERNALOCK® BLU SYSTEM | 73-5410 | BIOMET MICROFIXATION, INC | HRS | 00888233001083 |
| STERNALOCK® BLU SYSTEM | 73-5710 | BIOMET MICROFIXATION, INC | HRS | 00841036144821 |
| 2.4MM STERNALOCK (TM) SYSTEM | 71-2708 | BIOMET MICROFIXATION, INC | HRS | 00841036069872 |
| STERNALOCK® BLU SYSTEM | 73-5708 | BIOMET MICROFIXATION, INC | HRS | 00888233001144 |
| STERNALOCK® BLU SYSTEM | 73-2645 | BIOMET MICROFIXATION, INC | HRS | 00888233000994 |
| STERNALOCK® BLU SYSTEM | 73-5720 | BIOMET MICROFIXATION, INC | HRS | 00841036147938 |
| STERNALOCK® BLU SYSTEM | 73-2708 | BIOMET MICROFIXATION, INC | HRS | 00841036143398 |
| STERNALOCK BLU SYSTEM | SP-3245 | BIOMET MICROFIXATION, INC | HRS | 00888233018371 |
| STERNALOCK BLU SYSTEM | SP-3052 | BIOMET MICROFIXATION, INC | HRS | 00841036170257 |