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 |