510(k) K992970

DIGIT WIDGET by Hand Biomechanics Lab, Inc. — Product Code JDW

K992970 is an FDA 510(k) premarket notification submitted by Hand Biomechanics Lab, Inc. for the device "DIGIT WIDGET". The FDA issued a decision of Substantially Equivalent on November 8, 1999. The device falls under product code JDW (Pin, Fixation, Threaded), a Class II device regulated under 21 CFR 888.3040. Hand Biomechanics Lab, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 1999
Date Received
September 3, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pin, Fixation, Threaded
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type