Recognized a 510(k)/PMA number — showing its clearance record and devices.
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Novation Element | 165-30-08 | Exactech, Inc. | MEH | 10885862280633 |
| (unnamed) | 165-00-00 | Exactech, Inc. | MEH | 10885862661289 |
| Novation | 164-01-10 | Exactech, Inc. | MEH | 10885862035080 |
| Novation Element | 165-10-14 | Exactech, Inc. | MEH | 10885862249319 |
| Novation | 164-02-14 | Exactech, Inc. | MEH | 10885862035233 |
| Novation | 167-00-02 | Exactech, Inc. | MEH | 10885862035981 |
| Novation | 164-03-09 | Exactech, Inc. | MEH | 10885862035295 |
| Novation | 167-01-00 | Exactech, Inc. | MEH | 10885862661340 |
| (unnamed) | 165-00-06 | Exactech, Inc. | MEH | 10885862204172 |
| Novation Element | 165-00-18 | Exactech, Inc. | MEH | 10885862035639 |
| Novation | 167-00-03 | Exactech, Inc. | MEH | 10885862661326 |
| (unnamed) | 165-00-10 | Exactech, Inc. | MEH | 10885862035554 |
| Novation | 164-02-11 | Exactech, Inc. | MEH | 10885862035202 |
| Novation Element | 165-00-12 | Exactech, Inc. | MEH | 10885862035578 |
| Novation | 167-02-00 | Exactech, Inc. | MEH | 10885862036025 |
| Novation Element | 165-00-15 | Exactech, Inc. | MEH | 10885862035608 |
| Novation | 164-01-12 | Exactech, Inc. | MEH | 10885862035103 |
| Novation Element | 165-10-17 | Exactech, Inc. | MEH | 10885862249340 |
| Novation | 164-02-09 | Exactech, Inc. | MEH | 10885862035189 |
| Novation | 164-01-15 | Exactech, Inc. | MEH | 10885862035134 |
| Novation Element | 165-10-11 | Exactech, Inc. | MEH | 10885862249289 |
| Novation | 164-03-12 | Exactech, Inc. | MEH | 10885862035325 |
| Novation | 164-03-18 | Exactech, Inc. | MEH | 10885862035387 |
| Novation | 167-00-03 | Exactech, Inc. | MEH | 10885862035998 |
| Novation | 164-01-09 | Exactech, Inc. | MEH | 10885862035073 |