The following data is part of a premarket notification filed by Bionx Implants, Inc. with the FDA for Biofix Biodegradable Threaded Suture Anchor.
| Device ID | K972783 |
| 510k Number | K972783 |
| Device Name: | BIOFIX BIODEGRADABLE THREADED SUTURE ANCHOR |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | BIONX IMPLANTS, INC. 555 13TH STREET, N.W. Washington, DC 20004 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan BIONX IMPLANTS, INC. 555 13TH STREET, N.W. Washington, DC 20004 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-25 |
| Decision Date | 1998-04-14 |
| Summary: | summary |