K813581 is an FDA 510(k) clearance for the CRUCIATE LIGAMENT BUTTON. This device is classified as a Retention Device, Suture (Class I - General Controls, product code KGS).
Submitted by Biomet, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 23, 1982, 85 days after receiving the submission on December 28, 1981.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4930.
| 510(k) Number | K813581 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 28, 1981 |
| Decision Date | March 23, 1982 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | KGS — Retention Device, Suture |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4930 |