Hammer, Surgical
FDA product code FZY · Class I (low risk) · 21 CFR 878.4800 · General, Plastic Surgery
1510(k) clearances
0PMA approvals
2recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K802524 | Surgical HammersFZY · Traditional | Midshore Welding Corp. | 11/12/1980SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1870-2013 Class II | S-LIFT Slap Hammer, Part Number: 11-50204, Revision A The slap hammers are used…Malfunction of slap hammer. | SpineFrontier, Inc. | 04/25/2013Terminated |
| Z-2012-2008 | Trauma Fixation Systems - The Slotted Mallet is an auxiliary optional instrument…Customer complaint received regarding the separation of the mallet handle during a medical procedure. | Ebi, L.P. | 05/07/2008Terminated |