The following data is part of a premarket notification filed by Bionx Implants, Inc. with the FDA for Biosorbfx 1.5/2.0 Bioabsorbable Fixation System.
| Device ID | K982139 |
| 510k Number | K982139 |
| Device Name: | BIOSORBFX 1.5/2.0 BIOABSORBABLE FIXATION SYSTEM |
| Classification | Plate, Bone |
| Applicant | BIONX IMPLANTS, INC. 555 13TH STREET, N.W. Washington, DC 20004 |
| Contact | Johnathan S Kahan |
| Correspondent | Johnathan S Kahan BIONX IMPLANTS, INC. 555 13TH STREET, N.W. Washington, DC 20004 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-17 |
| Decision Date | 1998-09-15 |
| Summary: | summary |