The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Compact Cotrel -- Dubousset Spine System.
| Device ID | K921767 |
| 510k Number | K921767 |
| Device Name: | COMPACT COTREL -- DUBOUSSET SPINE SYSTEM |
| 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 | 1992-04-14 |
| Decision Date | 1993-06-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00673978109701 | K921767 | 000 |
| 00721902607585 | K921767 | 000 |
| 00721902607660 | K921767 | 000 |
| 00721902630453 | K921767 | 000 |
| 00673978026350 | K921767 | 000 |
| 00673978052540 | K921767 | 000 |
| 00673978052779 | K921767 | 000 |
| 00673978057453 | K921767 | 000 |
| 00673978057606 | K921767 | 000 |
| 00673978057705 | K921767 | 000 |
| 00673978082509 | K921767 | 000 |
| 00673978090931 | K921767 | 000 |
| 00673978109565 | K921767 | 000 |
| 00673978109589 | K921767 | 000 |
| 00673978109626 | K921767 | 000 |
| 00673978109664 | K921767 | 000 |
| 20673978111401 | K921767 | 000 |