The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Smf Titanium (ti) Alloy Bone Screws.
| Device ID | K963546 |
| 510k Number | K963546 |
| Device Name: | SMF TITANIUM (TI) ALLOY BONE SCREWS |
| Classification | Screw, Fixation, Intraosseous |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Contact | Angela J Silvestri |
| Correspondent | Angela J Silvestri SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE 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 | 1996-09-05 |
| Decision Date | 1997-06-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H980401065E0 | K963546 | 000 |
| H980400055E0 | K963546 | 000 |
| H980400056E0 | K963546 | 000 |
| H980400058E0 | K963546 | 000 |
| H980401041E0 | K963546 | 000 |
| H980401042E0 | K963546 | 000 |
| H980401043E0 | K963546 | 000 |
| H980401044E0 | K963546 | 000 |
| H980401061E0 | K963546 | 000 |
| H980401062E0 | K963546 | 000 |
| H980401063E0 | K963546 | 000 |
| H980401064E0 | K963546 | 000 |
| H980400054E0 | K963546 | 000 |