K950275 is an FDA 510(k) clearance for the RESORBABLE SOFT TISSUE ATTACHMENT DEVICE. This device is classified as a Fastener, Fixation, Biodegradable, Soft Tissue (Class II - Special Controls, product code MAI).
Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on November 7, 1995, 288 days after receiving the submission on January 23, 1995.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K950275 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | January 23, 1995 |
| Decision Date | November 07, 1995 |
| Days to Decision | 288 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 |