K811201 is an FDA 510(k) clearance for the EFTEKHAR ACETABULAR STANDOFF..
Submitted by Zimmer, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 21, 1981, 20 days after receiving the submission on May 1, 1981.
This device falls under the Orthopedic FDA review panel.
| 510(k) Number | K811201 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 1981 |
| Decision Date | May 21, 1981 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | — |
| Device Class | — |