K812064 is an FDA 510(k) clearance for the POLI-AXIAL KNEE CAGE. This device is classified as a Cage, Knee (Class I - General Controls, product code ITM).
Submitted by Generation II Orthotics, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 13, 1981, 23 days after receiving the submission on July 21, 1981.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3475.
| 510(k) Number | K812064 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 21, 1981 |
| Decision Date | August 13, 1981 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | ITM — Cage, Knee |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.3475 |