The following data is part of a premarket notification filed by Bionx Implants, Inc. with the FDA for Nugen Fx Screw.
| Device ID | K023022 |
| 510k Number | K023022 |
| Device Name: | NUGEN FX SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | BIONX IMPLANTS, INC. 1777 SENTRY PKWY. WEST, GWYNEDD HALL, SUITE 400 Blue Bell, PA 19422 |
| Contact | Gerard S Carlozzi |
| Correspondent | Gerard S Carlozzi BIONX IMPLANTS, INC. 1777 SENTRY PKWY. WEST, GWYNEDD HALL, SUITE 400 Blue Bell, PA 19422 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-11 |
| Decision Date | 2002-10-04 |
| Summary: | summary |