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FDA 510(k)

DEPUY SIGMA CR-F FEMORAL COMPONENT

K-Number: K082500 · 2008-11-18

ApplicantDePuy Orthopaedics, Inc.
Decision Date2008-11-18
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DEPUY SIGMA CR-F FEMORAL COMPONENT 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 2008-11-18 under 510(k) number K082500. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEPUY SIGMA CR-F FEMORAL COMPONENT?

DEPUY SIGMA CR-F FEMORAL COMPONENT is a medical device that received FDA 510(k) clearance on 2008-11-18. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K082500.

When did DEPUY SIGMA CR-F FEMORAL COMPONENT receive FDA 510(k) clearance?

DEPUY SIGMA CR-F FEMORAL COMPONENT received FDA 510(k) clearance on 2008-11-18, under 510(k) number K082500.

Who is the listed applicant for DEPUY SIGMA CR-F FEMORAL COMPONENT?

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 SIGMA CR-F FEMORAL COMPONENT?

The FDA product code for DEPUY SIGMA CR-F FEMORAL COMPONENT is JWH.

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Other records listing DePuy Orthopaedics, Inc. as applicant

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Related Devices (Code: JWH)

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.

K262057GMK ExtensionMedacta International SAK260063GSPE SpacerThe General Hospital Corporation, d/b/a MassachusettsK262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem ExtensionsB-One Ortho, Corp.K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.

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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