K961572 is an FDA 510(k) clearance for the VERSALOK SCREW ASSEMBLY (PROPOSED NAME). This device is classified as a Orthosis, Spondylolisthesis Spinal Fixation (Class II - Special Controls, product code MNH).
Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on September 17, 1996, 147 days after receiving the submission on April 23, 1996.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3070.
| 510(k) Number | K961572 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | April 23, 1996 |
| Decision Date | September 17, 1996 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | MNH — Orthosis, Spondylolisthesis Spinal Fixation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3070 |