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FDA 510(k)

FRAGMENT PLATE SYSTEM

K-Number: K061748 · 2006-07-17

ApplicantHand Innovations, LLC
Decision Date2006-07-17
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FRAGMENT PLATE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hand Innovations, LLC. It received FDA 510(k) clearance on 2006-07-17 under 510(k) number K061748. 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?

FRAGMENT PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 2006-07-17. The listed applicant is Hand Innovations, LLC. The 510(k) number is K061748.

When did FRAGMENT PLATE SYSTEM receive FDA 510(k) clearance?

FRAGMENT PLATE SYSTEM received FDA 510(k) clearance on 2006-07-17, under 510(k) number K061748.

Who is the listed applicant for FRAGMENT PLATE SYSTEM?

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

What is the FDA product code for FRAGMENT PLATE SYSTEM?

The FDA product code for FRAGMENT PLATE SYSTEM is KTT.

Related Clinical Trials

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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Other records listing Hand Innovations, LLC 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.

K060864MULTIDIRECTIONAL THREADED PEGK060294DIAPHYSEAL PLATEK060290SHOULDER FIXATION SYSTEMK052294SHOULDER NAIL PLATEK052248DORSAL NAIL PLATE, ANATOMICALK051728MODIFICATION TO SHOULDER FIXATION 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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