The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 6.5 Mm Cannulated Screw.
| Device ID | K021932 |
| 510k Number | K021932 |
| Device Name: | SYNTHES 6.5 MM CANNULATED SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Bonnie J Smith |
| Correspondent | Bonnie J Smith SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-12 |
| Decision Date | 2002-09-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6794084130 | K021932 | 000 |
| H6792084550 | K021932 | 000 |
| H6792084600 | K021932 | 000 |
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