K984442 is an FDA 510(k) clearance for the AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147. This device is classified as a Component, Traction, Invasive (Class II - Special Controls, product code JEC).
Submitted by Hand Biomechanics Lab, Inc. (Sacramento, US). The FDA issued a Cleared decision on February 12, 1999, 60 days after receiving the submission on December 14, 1998.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K984442 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 14, 1998 |
| Decision Date | February 12, 1999 |
| Days to Decision | 60 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 |