Cleared Traditional

AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147

K984442 · Hand Biomechanics Lab, Inc. · Orthopedic
Feb 1999
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K984442 is an FDA 510(k) clearance for the AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147, 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 review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K984442 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code JEC — Component, Traction, Invasive
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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