K950272 is an FDA 510(k) clearance for the PANALOK ABSORBABLE SUTURE ANCHOR SYSTEM. This device is classified as a Staple, Fixation, Bone (Class II - Special Controls, product code JDR).
Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on January 18, 1996, 360 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 | K950272 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | January 23, 1995 |
| Decision Date | January 18, 1996 |
| Days to Decision | 360 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | JDR — Staple, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |