The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Bone Staple(s).
| Device ID | K904553 |
| 510k Number | K904553 |
| Device Name: | BONE STAPLE(S) |
| Classification | Staple, Fixation, Bone |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Contact | Jim O'neill |
| Correspondent | Jim O'neill SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-05 |
| Decision Date | 1990-12-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679282820 | K904553 | 000 |
| H679282800 | K904553 | 000 |