K780225 is an FDA 510(k) clearance for the ORTHOSISES DEVICES. This device is classified as a Orthosis, Limb Brace (Class I - General Controls, product code IQI).
Submitted by Biomet, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 24, 1978, 15 days after receiving the submission on February 9, 1978.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3475.
| 510(k) Number | K780225 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 09, 1978 |
| Decision Date | February 24, 1978 |
| Days to Decision | 15 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 |