K811718 is an FDA 510(k) clearance for the SURFACE REPLACEMENT HIP PROSTHESIS. This device is classified as a Lens, Guide, Intraocular (Class I - General Controls, product code KYB).
Submitted by Biomet, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 18, 1981, 92 days after receiving the submission on June 18, 1981.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4300.
| 510(k) Number | K811718 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 18, 1981 |
| Decision Date | September 18, 1981 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | KYB — Lens, Guide, Intraocular |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4300 |