The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Anterior Spine System.
Device ID | K934429 |
510k Number | K934429 |
Device Name: | ANTERIOR SPINE SYSTEM |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
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 | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-09-13 |
Decision Date | 1994-10-20 |