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FDA 510(k)

MODIFICATION TO SMALL BONE FIXATION SYSTEM

K-Number: K041157 · 2004-07-30

ApplicantHand Innovations, Inc.
Decision Date2004-07-30
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO SMALL BONE FIXATION SYSTEM 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 2004-07-30 under 510(k) number K041157. 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 MODIFICATION TO SMALL BONE FIXATION SYSTEM?

MODIFICATION TO SMALL BONE FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2004-07-30. The listed applicant is Hand Innovations, Inc.. The 510(k) number is K041157.

When did MODIFICATION TO SMALL BONE FIXATION SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO SMALL BONE FIXATION SYSTEM received FDA 510(k) clearance on 2004-07-30, under 510(k) number K041157.

Who is the listed applicant for MODIFICATION TO SMALL BONE FIXATION SYSTEM?

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 MODIFICATION TO SMALL BONE FIXATION SYSTEM?

The FDA product code for MODIFICATION TO SMALL BONE FIXATION SYSTEM 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 SYSTEMK041081FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRESK033406SMALL BONE FIXATION SYSTEMK032705DISTAL RADIUS FRACTURE REPAIR SYSTEMK030198HAND INNOVATIONS, INC. DISTAL RADIUS FRACTURE REPAIR SYSTEM

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Related Devices (Code: HTY)

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.

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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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