Saw, Pneumatically Powered
FDA product code KFK · Class I (low risk) · 21 CFR 878.4820 · General, Plastic Surgery
4510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K893949 | #157 Exam LightKFK · Traditional | Medmark, Inc. | 08/07/1989SE |
| K894301 | Micro-Aire Sternum Saw 4800KFK · Traditional | Micro Surgical Instruments Corp. | 08/03/1989SE |
| K870157 | Oscillating Saw/ Reciprocating Saw/ Drill-ReamerKFK · Traditional | Micro-Aire Surgical Instruments, Inc. | 02/24/1987SE |
| K801737 | Sternum SawKFK · Traditional | Amsco Co. | 08/20/1980SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0179-2007 | ConMed Linvatec Sternum Saw Collet Nut, Catalog Number 5059-09: Used on ConMed Linvatec…The Sternum Saw Collet Nut that is used to insert and hold the saw blade in place may not always allow for… | Linvatec Corp. | 12/20/2005Terminated |