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FDA 510(k)

INTRAMEDULLARY FIXATION SYSTEM FOR THE HAND

K-Number: K013424 · 2001-12-20

ApplicantHand Innovations, Inc.
Decision Date2001-12-20
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INTRAMEDULLARY FIXATION SYSTEM FOR THE HAND is the device name listed in this FDA 510(k) record. The listed applicant is Hand Innovations, Inc.. It received FDA 510(k) clearance on 2001-12-20 under 510(k) number K013424. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRAMEDULLARY FIXATION SYSTEM FOR THE HAND?

INTRAMEDULLARY FIXATION SYSTEM FOR THE HAND is a medical device that received FDA 510(k) clearance on 2001-12-20. The listed applicant is Hand Innovations, Inc.. The 510(k) number is K013424.

When did INTRAMEDULLARY FIXATION SYSTEM FOR THE HAND receive FDA 510(k) clearance?

INTRAMEDULLARY FIXATION SYSTEM FOR THE HAND received FDA 510(k) clearance on 2001-12-20, under 510(k) number K013424.

Who is the listed applicant for INTRAMEDULLARY FIXATION SYSTEM FOR THE HAND?

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

What is the FDA product code for INTRAMEDULLARY FIXATION SYSTEM FOR THE HAND?

The FDA product code for INTRAMEDULLARY FIXATION SYSTEM FOR THE HAND is HTY.

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Other records listing Hand Innovations, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K050932DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEMK042059SHOULDER FIXATION SYSTEMK041157MODIFICATION TO SMALL BONE FIXATION SYSTEMK041081FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRESK033406SMALL BONE FIXATION SYSTEMK032705DISTAL RADIUS FRACTURE REPAIR SYSTEM

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Related Devices (Code: HTY)

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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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