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FDA 510(k)

DEPUY SIGMA XLK TIBIAL INSERTS

K-Number: K040166 · 2004-02-23

ApplicantDePuy Orthopaedics, Inc.
Decision Date2004-02-23
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DEPUY SIGMA XLK TIBIAL INSERTS 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 2004-02-23 under 510(k) number K040166. 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 XLK TIBIAL INSERTS?

DEPUY SIGMA XLK TIBIAL INSERTS is a medical device that received FDA 510(k) clearance on 2004-02-23. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K040166.

When did DEPUY SIGMA XLK TIBIAL INSERTS receive FDA 510(k) clearance?

DEPUY SIGMA XLK TIBIAL INSERTS received FDA 510(k) clearance on 2004-02-23, under 510(k) number K040166.

Who is the listed applicant for DEPUY SIGMA XLK TIBIAL INSERTS?

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 XLK TIBIAL INSERTS?

The FDA product code for DEPUY SIGMA XLK TIBIAL INSERTS 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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