K092044 is an FDA 510(k) clearance for the ORTHOCOR KNEE SYSTEM, MEDIAN, LARGE, X-LARGE. This device is classified as a Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat (Class II - Special Controls, product code ILX).
Submitted by Orthocor Medical (Mccordsville, US). The FDA issued a Cleared decision on December 18, 2009, 165 days after receiving the submission on July 6, 2009.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5290.
| 510(k) Number | K092044 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 2009 |
| Decision Date | December 18, 2009 |
| Days to Decision | 165 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | ILX — Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5290 |