The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman(tm) Titanium Interlaminar Clamp Kit.
Device ID | K924142 |
510k Number | K924142 |
Device Name: | CODMAN(TM) TITANIUM INTERLAMINAR CLAMP KIT |
Classification | Appliance, Fixation, Spinal Interlaminal |
Applicant | Codman & Shurtleff, Inc. C/O BURCKMAN CO., INC. 1000 BURNETT AVENUE, SUITE 250 Concord, CA 94520 |
Contact | David W Schlerf |
Correspondent | David W Schlerf Codman & Shurtleff, Inc. C/O BURCKMAN CO., INC. 1000 BURNETT AVENUE, SUITE 250 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 | 1992-08-17 |
Decision Date | 1993-06-15 |