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FDA 510(k)

FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES

K-Number: K041081 · 2004-07-01

ApplicantHand Innovations, Inc.
Decision Date2004-07-01
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES 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 2004-07-01 under 510(k) number K041081. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES?

FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES is a medical device that received FDA 510(k) clearance on 2004-07-01. The listed applicant is Hand Innovations, Inc.. The 510(k) number is K041081.

When did FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES receive FDA 510(k) clearance?

FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES received FDA 510(k) clearance on 2004-07-01, under 510(k) number K041081.

Who is the listed applicant for FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES?

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 FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES?

The FDA product code for FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES is KTT.

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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 SYSTEMK033406SMALL BONE FIXATION SYSTEMK032705DISTAL RADIUS FRACTURE REPAIR SYSTEMK030198HAND INNOVATIONS, INC. DISTAL RADIUS FRACTURE REPAIR SYSTEM

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Related Devices (Code: KTT)

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.

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLCK260900DYNEX® External Fixation SystemsVilex, LLCK260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean GlobalK253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.K253202Hoffmann LRF SystemStryker GmbH

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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