Cleared Traditional

DIGIT WIDGET

K992970 · Hand Biomechanics Lab, Inc. · Orthopedic
Nov 1999
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K992970 is an FDA 510(k) clearance for the DIGIT WIDGET, a Pin, Fixation, Threaded (Class II — Special Controls, product code JDW), submitted by Hand Biomechanics Lab, Inc. (Sacramento, US). The FDA issued a Cleared decision on November 8, 1999, 66 days after receiving the submission on September 3, 1999. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K992970 FDA.gov
FDA Decision Cleared SESE
Date Received September 03, 1999
Decision Date November 08, 1999
Days to Decision 66 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDW — Pin, Fixation, Threaded
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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