K952687 is an FDA 510(k) clearance for the PANALOK WEDGE ABSORABLE SUTURE ANCHOR SYSTEM. This device is classified as a Fastener, Fixation, Biodegradable, Soft Tissue (Class II - Special Controls, product code MAI).
Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on February 6, 1996, 239 days after receiving the submission on June 12, 1995.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K952687 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | June 12, 1995 |
| Decision Date | February 06, 1996 |
| Days to Decision | 239 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | MAI — Fastener, Fixation, Biodegradable, Soft Tissue |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |