K811456 is an FDA 510(k) clearance for the ORTHO-FRAC KIT. This device is classified as a Orthosis, Limb Brace (Class I - General Controls, product code IQI).
Submitted by Orthomedics (Mchenry, US). The FDA issued a Cleared decision on June 12, 1981, 21 days after receiving the submission on May 22, 1981.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3475.
| 510(k) Number | K811456 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 22, 1981 |
| Decision Date | June 12, 1981 |
| Days to Decision | 21 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 |