The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 7.0/7.3 Mm Cannulated Screws.
| Device ID | K962011 |
| 510k Number | K962011 |
| Device Name: | SYNTHES 7.0/7.3 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 | 1996-05-23 |
| Decision Date | 1996-08-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6792088700 | K962011 | 000 |
| H6792088650 | K962011 | 000 |