The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Cotrel - Dubousset Spine Implants.
| Device ID | K921056 |
| 510k Number | K921056 |
| Device Name: | COTREL - DUBOUSSET SPINE IMPLANTS |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | BUCKMAN CO., INC. 1000 BURNETT AVE. SUITE 450 Concord, CA 94520 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf BUCKMAN CO., INC. 1000 BURNETT AVE. SUITE 450 Concord, CA 94520 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-05 |
| Decision Date | 1993-06-24 |