K892651 is an FDA 510(k) clearance for the SONGER WIRING SYSTEM. This device is classified as a Wire, Surgical (Class II - Special Controls, product code LRN).
Submitted by Danek Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on July 25, 1989, 103 days after receiving the submission on April 13, 1989.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K892651 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 13, 1989 |
| Decision Date | July 25, 1989 |
| Days to Decision | 103 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | LRN — Wire, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |