K812422 is an FDA 510(k) clearance for the CUSTOM CONTOUR LUMBOSACRAL ORTHOSIS. This device is classified as a Orthosis, Lumbo-sacral (Class I - General Controls, product code IPY).
Submitted by Surgical Appliance Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 14, 1981, 21 days after receiving the submission on August 24, 1981.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3490.
| 510(k) Number | K812422 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 24, 1981 |
| Decision Date | September 14, 1981 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | IPY — Orthosis, Lumbo-sacral |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.3490 |