Cleared Traditional

WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347, CFD-347-NS

K033112 · Hand Biomechanics Lab, Inc. · Orthopedic

Nov 2003

Decision

36d

Days

Class 2

Risk

About This 510(k) Submission

K033112 is an FDA 510(k) clearance for the WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347, CFD-347-NS, a Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (Class II — Special Controls, product code KTT), submitted by Hand Biomechanics Lab, Inc. (Sacramento, US). The FDA issued a Cleared decision on November 5, 2003, 36 days after receiving the submission on September 30, 2003. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K033112 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2003
Decision Date	November 05, 2003
Days to Decision	36 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KTT — Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3030