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 |