K811297 is an FDA 510(k) clearance for the CERVICAL SUPPORT. This device is classified as a Orthosis, Cervical-thoracic, Rigid (Class I - General Controls, product code IQF).
Submitted by Orthomedics (Mchenry, US). The FDA issued a Cleared decision on May 27, 1981, 16 days after receiving the submission on May 11, 1981.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3490.
| 510(k) Number | K811297 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 11, 1981 |
| Decision Date | May 27, 1981 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | IQF — Orthosis, Cervical-thoracic, Rigid |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.3490 |