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FDA 510(k)

FRAGMENT SPECIFIC FIXATOR

K-Number: K052498 · 2005-10-17

ApplicantDavid J. Slutsky MD
Decision Date2005-10-17
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FRAGMENT SPECIFIC FIXATOR is the device name listed in this FDA 510(k) record. The listed applicant is David J. Slutsky MD. It received FDA 510(k) clearance on 2005-10-17 under 510(k) number K052498. 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 SPECIFIC FIXATOR?

FRAGMENT SPECIFIC FIXATOR is a medical device that received FDA 510(k) clearance on 2005-10-17. The listed applicant is David J. Slutsky MD. The 510(k) number is K052498.

When did FRAGMENT SPECIFIC FIXATOR receive FDA 510(k) clearance?

FRAGMENT SPECIFIC FIXATOR received FDA 510(k) clearance on 2005-10-17, under 510(k) number K052498.

Who is the listed applicant for FRAGMENT SPECIFIC FIXATOR?

The FDA 510(k) record lists David J. Slutsky MD as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FRAGMENT SPECIFIC FIXATOR?

The FDA product code for FRAGMENT SPECIFIC FIXATOR is KTT.

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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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