Recognized a 510(k)/PMA number — showing its clearance record and devices.
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| SOLAR | 5350-5021 | Howmedica Osteonics Corp. | HSD KWS | 07613327137866 |
| ReUnion | R5350-4015 | Howmedica Osteonics Corp. | HSD KWS | 07613327139402 |
| ReUnion | R5350-4512 | Howmedica Osteonics Corp. | HSD KWS | 07613327139433 |
| ReUnion | R5350-5018 | Howmedica Osteonics Corp. | HSD KWS | 07613327139464 |
| ReUnion | R5350-5518 | Howmedica Osteonics Corp. | HSD KWS | 07613327139556 |
| ReUnion | R5350-5028 | Howmedica Osteonics Corp. | HSD KWS | 07613327139587 |
| ReUnion | R5350-4521 | Howmedica Osteonics Corp. | HSD KWS | 07613327139457 |
| ReUnion | R5350-4018 | Howmedica Osteonics Corp. | HSD KWS | 07613327139471 |
| ReUnion | R5350-5528 | Howmedica Osteonics Corp. | HSD KWS | 07613327139549 |
| SOLAR | 5350-5524 | Howmedica Osteonics Corp. | HSD KWS | 07613327137903 |
| ReUnion | R5350-4021 | Howmedica Osteonics Corp. | HSD KWS | 07613327139426 |
| SOLAR | 5350-4518 | Howmedica Osteonics Corp. | HSD KWS | 07613327137811 |
| SOLAR | 5350-4512 | Howmedica Osteonics Corp. | HSD KWS | 07613327137781 |
| SOLAR | 5350-5518 | Howmedica Osteonics Corp. | HSD KWS | 07613327137873 |
| ReUnion | R5350-4518 | Howmedica Osteonics Corp. | HSD KWS | 07613327139501 |
| SOLAR | 5350-5534 | Howmedica Osteonics Corp. | HSD KWS | 07613327137965 |
| SOLAR | 5350-4521 | Howmedica Osteonics Corp. | HSD KWS | 07613327137804 |
| ReUnion | R5350-5024 | Howmedica Osteonics Corp. | HSD KWS | 07613327139532 |
| SOLAR | 5350-5015 | Howmedica Osteonics Corp. | HSD KWS | 07613327137842 |
| ReUnion | R5350-5521 | Howmedica Osteonics Corp. | HSD KWS | 07613327139518 |
| SOLAR | 5350-4021 | Howmedica Osteonics Corp. | HSD KWS | 07613327137828 |
| SOLAR | 5350-4018 | Howmedica Osteonics Corp. | HSD KWS | 07613327137736 |
| SOLAR | 5350-5528 | Howmedica Osteonics Corp. | HSD KWS | 07613327138023 |
| SOLAR | 5350-4524 | Howmedica Osteonics Corp. | HSD KWS | 07613327137996 |
| SOLAR | 5350-4515 | Howmedica Osteonics Corp. | HSD KWS | 07613327137798 |