F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE

Component, Traction, Invasive

HAND BIOMECHANICS LAB, INC.

The following data is part of a premarket notification filed by Hand Biomechanics Lab, Inc. with the FDA for F3 Fractured Finger Fixator, Sterile (model: Fcs 400) And Non Sterile.

Pre-market Notification Details

• Device ID: K072432
• 510k Number: K072432
• Device Name: F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE
• Classification: Component, Traction, Invasive
• Applicant: HAND BIOMECHANICS LAB, INC. 77 SCRIPPS DR., SUITE 104 Sacramento, CA 95825
• Contact: Jeff Woodhouse
• Correspondent: Jeff Woodhouse; HAND BIOMECHANICS LAB, INC. 77 SCRIPPS DR., SUITE 104 Sacramento, CA 95825
• Product Code: JEC
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-08-29
• Decision Date: 2008-01-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00861994000229	K072432	000