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FDA 510(k)

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

K-Number: K072432 · 2008-01-09

ApplicantHand Biomechanics Lab, Inc.
Decision Date2008-01-09
Product CodeJEC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Hand Biomechanics Lab, Inc.. It received FDA 510(k) clearance on 2008-01-09 under 510(k) number K072432. The device is classified under product code JEC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE?

F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE is a medical device that received FDA 510(k) clearance on 2008-01-09. The listed applicant is Hand Biomechanics Lab, Inc.. The 510(k) number is K072432.

When did F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE receive FDA 510(k) clearance?

F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE received FDA 510(k) clearance on 2008-01-09, under 510(k) number K072432.

Who is the listed applicant for F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE?

The FDA 510(k) record lists Hand Biomechanics Lab, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE?

The FDA product code for F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE is JEC.

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Other records listing Hand Biomechanics Lab, Inc. as applicant

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Related Devices (Code: JEC)

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K203605SteriTrakArbutus Medical, Inc.K193256Anjon Bremer Halo SystemAnjon Holdings, LLCK192465DigiFix Sterile KitVirak Orthopedics, LLCK181192PIP FixHand Biomechanics Lab, Inc.K171863Anjon Bremer Halo SystemAnjon Holdings, LLCK163028Medline ReNewal Reprocessed Stryker External Fixation DevicesSurgical Instrument Service and Savings, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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