The following data is part of a premarket notification filed by Bionx Implants, Ltd. with the FDA for Smartscrew Model 222006...227510.
| Device ID | K003077 |
| 510k Number | K003077 |
| Device Name: | SMARTSCREW MODEL 222006...227510 |
| Classification | Screw, Fixation, Bone |
| Applicant | BIONX IMPLANTS, LTD. 1777 SENTRY PARKWAY WEST Bluebell, PA 19422 |
| Contact | Gerard S Carlozzi |
| Correspondent | Gerard S Carlozzi BIONX IMPLANTS, LTD. 1777 SENTRY PARKWAY WEST Bluebell, PA 19422 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-03 |
| Decision Date | 2001-04-26 |