The following data is part of a premarket notification filed by Davis & Geck, Inc. with the FDA for Biofix* Biodegradable Fixation Rod.
| Device ID | K890902 |
| 510k Number | K890902 |
| Device Name: | BIOFIX* BIODEGRADABLE FIXATION ROD |
| Classification | Pin, Fixation, Smooth |
| Applicant | DAVIS & GECK, INC. AMERICAN CYNAMID COMPANY ONE CASPER STREET Danbury, CT 06810 |
| Contact | R. I Pelletier |
| Correspondent | R. I Pelletier DAVIS & GECK, INC. AMERICAN CYNAMID COMPANY ONE CASPER STREET Danbury, CT 06810 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-22 |
| Decision Date | 1989-11-03 |