K974435 is an FDA 510(k) clearance for the MICHELSON ANTERIOR CERVICAL PLATE SYSTEM. This device is classified as a Appliance, Fixation, Spinal Intervertebral Body (Class II - Special Controls, product code KWQ).
Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on February 19, 1998, 87 days after receiving the submission on November 24, 1997.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3060.
| 510(k) Number | K974435 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | November 24, 1997 |
| Decision Date | February 19, 1998 |
| Days to Decision | 87 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 |