AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147— 510(k) K984442

Clearance details

Applicant

Hand Biomechanics Lab, Inc.

Product code

Code JEC

Device class

Class 2

Regulation

21 CFR 888.3040

Advisory panel

Orthopedic

Date received

1998-12-14

Decision date

1999-02-12

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Sacramento, CA, US

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• Z-0136-2017 — 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. This is a single use system used for a trauma related surgery The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. The non-perishable sterile system is packaged in an inner then outer tray and shipped in a cardboard shelf box. Orthopedic:The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures.Class II·Terminated·Hand Biomechanics Lab Inc·20160914

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K984442.