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FDA 510(k)

DEPUY GCK FEMORAL AND TIBIAL COMPONENTS

K-Number: K070849 · 2007-06-26

ApplicantDePuy Orthopaedics, Inc.
Decision Date2007-06-26
Product CodeNPJ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DEPUY GCK FEMORAL AND TIBIAL COMPONENTS is the device name listed in this FDA 510(k) record. The listed applicant is DePuy Orthopaedics, Inc.. It received FDA 510(k) clearance on 2007-06-26 under 510(k) number K070849. The device is classified under product code NPJ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEPUY GCK FEMORAL AND TIBIAL COMPONENTS?

DEPUY GCK FEMORAL AND TIBIAL COMPONENTS is a medical device that received FDA 510(k) clearance on 2007-06-26. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K070849.

When did DEPUY GCK FEMORAL AND TIBIAL COMPONENTS receive FDA 510(k) clearance?

DEPUY GCK FEMORAL AND TIBIAL COMPONENTS received FDA 510(k) clearance on 2007-06-26, under 510(k) number K070849.

Who is the listed applicant for DEPUY GCK FEMORAL AND TIBIAL COMPONENTS?

The FDA 510(k) record lists DePuy Orthopaedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEPUY GCK FEMORAL AND TIBIAL COMPONENTS?

The FDA product code for DEPUY GCK FEMORAL AND TIBIAL COMPONENTS is NPJ.

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Other records listing DePuy Orthopaedics, Inc. as applicant

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Related Devices (Code: NPJ)

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.

K133039RESTORIS MULTICOMPARTMENTAL KNEE SYSTEMMako Surgical CorporationK093513IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEMConformis, Inc.K093056SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEMSmith & Nephew, Inc.K090763RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEMMako Surgical CorporationK061648DEPUY GRADUATED COMPARTMENTAL KNEE (GCK)DePuy Orthopaedics, Inc.K061569SMITH & NEPHEW COMPETITOR DEUCE FEMORAL COMPONENTSSmith & Nephew, Inc.

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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