K790262 is an FDA 510(k) clearance for the UNIVERSAL EXTERNAL FIXATION ASSEMBLY. This device is classified as a Component, Traction, Invasive (Class II - Special Controls, product code JEC).
Submitted by Zimmer, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 13, 1979, 7 days after receiving the submission on February 6, 1979.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K790262 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 06, 1979 |
| Decision Date | February 13, 1979 |
| Days to Decision | 7 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | JEC — Component, Traction, Invasive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |