The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Spiked Washer.
| Device ID | K011583 |
| 510k Number | K011583 |
| Device Name: | SPIKED WASHER |
| Classification | Washer, Bolt Nut |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Contact | Thomas M Maguire |
| Correspondent | Thomas M Maguire 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 | 2001-05-23 |
| Decision Date | 2002-01-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6792199510 | K011583 | 000 |
| H6792199410 | K011583 | 000 |
| H6792199310 | K011583 | 000 |