K936269 is an FDA 510(k) clearance for the CASPAR TITANIUM ALLOY BONE SCREWS. This device is classified as a Appliance, Fixation, Spinal Intervertebral Body (Class II - Special Controls, product code KWQ).
Submitted by Aesculap, Inc. (South San Francisco, US). The FDA issued a Cleared decision on August 15, 1994, 228 days after receiving the submission on December 30, 1993.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3060.
| 510(k) Number | K936269 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | December 30, 1993 |
| Decision Date | August 15, 1994 |
| Days to Decision | 228 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | KWQ — Appliance, Fixation, Spinal Intervertebral Body |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3060 |