The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Smf Stainless Steel Bone Screws.
| Device ID | K964261 |
| 510k Number | K964261 |
| Device Name: | SMF STAINLESS STEEL BONE SCREWS |
| Classification | Screw, Fixation, Intraosseous |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. P.O. BOX 1766 Paoli, PA 19301 |
| Contact | Angela J Silvestri |
| Correspondent | Angela J Silvestri SYNTHES (USA) 1690 RUSSELL RD. P.O. BOX 1766 Paoli, PA 19301 |
| Product Code | DZL |
| CFR Regulation Number | 872.4880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-25 |
| Decision Date | 1997-04-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H9802015140 | K964261 | 000 |
| H9802015120 | K964261 | 000 |
| H9802015100 | K964261 | 000 |
| H9802015080 | K964261 | 000 |