The following data is part of a premarket notification filed by Biodynamic Technologies, Inc. with the FDA for Fx-cablelok(tm) Stop(trochanter Hook) System.
| Device ID | K935646 |
| 510k Number | K935646 |
| Device Name: | FX-CABLELOK(TM) STOP(TROCHANTER HOOK) SYSTEM |
| Classification | Cerclage, Fixation |
| Applicant | BIODYNAMIC TECHNOLOGIES, INC. 1000 BURNETT AVE. SUITE 250 Concord, CA 94520 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf BIODYNAMIC TECHNOLOGIES, INC. 1000 BURNETT AVE. SUITE 250 Concord, CA 94520 |
| Product Code | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-23 |
| Decision Date | 1994-03-09 |