510(k) K072432

F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE by Hand Biomechanics Lab, Inc. — Product Code JEC

K072432 is an FDA 510(k) premarket notification submitted by Hand Biomechanics Lab, Inc. for the device "F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE". The FDA issued a decision of Substantially Equivalent on January 9, 2008. The device falls under product code JEC (Component, Traction, Invasive), 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
January 9, 2008
Date Received
August 29, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Component, Traction, Invasive
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type