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FDA 510(k)

IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM

K-Number: K093513 · 2009-12-16

ApplicantConformis, Inc.
Decision Date2009-12-16
Product CodeNPJ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Conformis, Inc.. It received FDA 510(k) clearance on 2009-12-16 under 510(k) number K093513. 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 IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM?

IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM is a medical device that received FDA 510(k) clearance on 2009-12-16. The listed applicant is Conformis, Inc.. The 510(k) number is K093513.

When did IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM receive FDA 510(k) clearance?

IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM received FDA 510(k) clearance on 2009-12-16, under 510(k) number K093513.

Who is the listed applicant for IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM?

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

What is the FDA product code for IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM?

The FDA product code for IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM is NPJ.

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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 CorporationK093056SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEMSmith & Nephew, Inc.K090763RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEMMako Surgical CorporationK070849DEPUY GCK FEMORAL AND TIBIAL COMPONENTSDePuy Orthopaedics, Inc.K061648DEPUY 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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