The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Sterile 3.5 Mm And 4.0 Mm Cannulated Screws.
| Device ID | K963192 |
| 510k Number | K963192 |
| Device Name: | SYNTHES STERILE 3.5 MM AND 4.0 MM CANNULATED SCREWS |
| Classification | Screw, Fixation, Bone |
| 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-15 |
| Decision Date | 1996-11-08 |
| Summary: | summary |