K760002 is an FDA 510(k) clearance for the KNEE AID. This device is classified as a Orthosis, Limb Brace (Class I - General Controls, product code IQI).
Submitted by Zimmer, Inc. (1831 Olive St. St. Louis, US). The FDA issued a Cleared decision on July 26, 1976, 61 days after receiving the submission on May 26, 1976.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3475.
| 510(k) Number | K760002 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 26, 1976 |
| Decision Date | July 26, 1976 |
| Days to Decision | 61 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | IQI — Orthosis, Limb Brace |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.3475 |