510(k) K984442 ยท JEC Component, Traction, Invasive
AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147
| Applicant | Hand Biomechanics Lab, Inc., Sacramento CA, US |
| Decision | Substantially Equivalent, Feb 12, 1999 |
| Received | Dec 14, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984442
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 14, 2016 | Hand Biomechanics Lab Inc Agee-WristJack Fracture Reduction System;
Item number: CFD-147.
The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. T Terminated |
JEC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.