K823397 is an FDA 510(k) clearance for the ANATOMIC FRACTURE BRACE. This device is classified as a Joint, Knee, External Brace (Class I - General Controls, product code ITQ).
Submitted by Orthopedic Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 29, 1982, 17 days after receiving the submission on November 12, 1982.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3475.
| 510(k) Number | K823397 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 12, 1982 |
| Decision Date | November 29, 1982 |
| Days to Decision | 17 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | ITQ — Joint, Knee, External Brace |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.3475 |