The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Spiked Washer.
| Device ID | K914472 |
| 510k Number | K914472 |
| Device Name: | SPIKED WASHER |
| Classification | Washer, Bolt Nut |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Contact | Diane Cochet-wynant |
| Correspondent | Diane Cochet-wynant SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Product Code | HTN |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-07 |
| Decision Date | 1991-11-07 |