K944092 is an FDA 510(k) clearance for the ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEM. This device is classified as a Component, Traction, Invasive (Class II - Special Controls, product code JEC).
Submitted by Orthofix Srl (Rockville, US). The FDA issued a Cleared decision on April 4, 1995, 225 days after receiving the submission on August 22, 1994.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K944092 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 22, 1994 |
| Decision Date | April 04, 1995 |
| Days to Decision | 225 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JEC — Component, Traction, Invasive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |