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FDA 510(k)

ILIZAROV EXTERNAL FIXATION SYSTEM

K-Number: K962808 · 1996-08-19

ApplicantSmith & Nephew Richards, Inc.
Decision Date1996-08-19
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ILIZAROV EXTERNAL FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Richards, Inc.. It received FDA 510(k) clearance on 1996-08-19 under 510(k) number K962808. 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 ILIZAROV EXTERNAL FIXATION SYSTEM?

ILIZAROV EXTERNAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 1996-08-19. The listed applicant is Smith & Nephew Richards, Inc.. The 510(k) number is K962808.

When did ILIZAROV EXTERNAL FIXATION SYSTEM receive FDA 510(k) clearance?

ILIZAROV EXTERNAL FIXATION SYSTEM received FDA 510(k) clearance on 1996-08-19, under 510(k) number K962808.

Who is the listed applicant for ILIZAROV EXTERNAL FIXATION SYSTEM?

The FDA 510(k) record lists Smith & Nephew Richards, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ILIZAROV EXTERNAL FIXATION SYSTEM?

The FDA product code for ILIZAROV EXTERNAL FIXATION SYSTEM is KTT.

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Other records listing Smith & Nephew Richards, 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.

K965224EMPOWER ANTERIOR DIRECT SCREWSK963509GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRONK960444FINN ROD TO ROD CONNECTORK964163TRIMAX NAIL SYSTEMK962557GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENTK963486REVISION HIP 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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