The following data is part of a premarket notification filed by Bionx Implants, Inc. with the FDA for Biosorbfx Tack And Biosorbpdx Tack Bioabsorbable Fixation Fastener, Used With Plates.
| Device ID | K003756 |
| 510k Number | K003756 |
| Device Name: | BIOSORBFX TACK AND BIOSORBPDX TACK BIOABSORBABLE FIXATION FASTENER, USED WITH PLATES |
| Classification | Plate, Bone |
| Applicant | BIONX IMPLANTS, INC. 1777 SENTRY PKWY. WEST, GWYNEDD HALL, SUITE 400 Blue Bell, PA 19422 |
| Contact | David W Anderson |
| Correspondent | David W Anderson BIONX IMPLANTS, INC. 1777 SENTRY PKWY. WEST, GWYNEDD HALL, SUITE 400 Blue Bell, PA 19422 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-06 |
| Decision Date | 2001-01-03 |