K812401 is an FDA 510(k) clearance for the CRUCIFORM ANTERIOR SPINAL HYPEREXTEN. O. This device is classified as a Orthosis, Thoracic (Class I - General Controls, product code IPT).
Submitted by Surgical Appliance Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 14, 1981, 25 days after receiving the submission on August 20, 1981.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3490.
| 510(k) Number | K812401 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 20, 1981 |
| Decision Date | September 14, 1981 |
| Days to Decision | 25 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | IPT — Orthosis, Thoracic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.3490 |