The following data is part of a premarket notification filed by Encore Orthopedics, Inc. with the FDA for 6.5 Mm Cancellous Bone Screw.
| Device ID | K931665 |
| 510k Number | K931665 |
| Device Name: | 6.5 MM CANCELLOUS BONE SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | ENCORE ORTHOPEDICS, INC. 8920 BUSINESS PARK DR. SUTIE 380 Austin, TX 78759 |
| Contact | Webb |
| Correspondent | Webb ENCORE ORTHOPEDICS, INC. 8920 BUSINESS PARK DR. SUTIE 380 Austin, TX 78759 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-05 |
| Decision Date | 1994-02-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888912070089 | K931665 | 000 |
| 00888912069960 | K931665 | 000 |
| 00888912069977 | K931665 | 000 |
| 00888912069984 | K931665 | 000 |
| 00888912070003 | K931665 | 000 |
| 00888912070010 | K931665 | 000 |
| 00888912070027 | K931665 | 000 |
| 00888912070034 | K931665 | 000 |
| 00888912070041 | K931665 | 000 |
| 00888912070058 | K931665 | 000 |
| 00888912070065 | K931665 | 000 |
| 00888912070072 | K931665 | 000 |
| 00888912069946 | K931665 | 000 |