K842343 is an FDA 510(k) clearance for the SABA-COOMBS MINI EXTERNAL FIXATOR. 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 September 11, 1984, 89 days after receiving the submission on June 14, 1984.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K842343 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 14, 1984 |
| Decision Date | September 11, 1984 |
| Days to Decision | 89 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 |