The following data is part of a premarket notification filed by Bio-tech Co. with the FDA for Fx-cablelok System.
| Device ID | K922142 |
| 510k Number | K922142 |
| Device Name: | FX-CABLELOK SYSTEM |
| Classification | Cerclage, Fixation |
| Applicant | BIO-TECH CO. 727 TWENTY-THIRD ST. SOUTH Arlington, VA 22202 |
| Contact | Andrew E Taylor |
| Correspondent | Andrew E Taylor BIO-TECH CO. 727 TWENTY-THIRD ST. SOUTH Arlington, VA 22202 |
| Product Code | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-06 |
| Decision Date | 1992-11-20 |