The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Fx-cablelok Cable/plate System.
| Device ID | K935950 |
| 510k Number | K935950 |
| Device Name: | FX-CABLELOK CABLE/PLATE SYSTEM |
| Classification | Cerclage, Fixation |
| Applicant | BUCKMAN CO., INC. 100 BURNETT AVE. SUITE 250 Concord, CA 94520 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf BUCKMAN CO., INC. 100 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 | 1993-12-13 |
| Decision Date | 1994-03-09 |