K924142 is an FDA 510(k) clearance for the CODMAN(TM) TITANIUM INTERLAMINAR CLAMP KIT. This device is classified as a Appliance, Fixation, Spinal Interlaminal (Class II - Special Controls, product code KWP).
Submitted by Codman & Shurtleff, Inc. (Concord, US). The FDA issued a Cleared decision on June 15, 1993, 302 days after receiving the submission on August 17, 1992.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3050.
| 510(k) Number | K924142 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 17, 1992 |
| Decision Date | June 15, 1993 |
| Days to Decision | 302 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWP - Appliance, Fixation, Spinal Interlaminal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3050 |