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FDA 510(k)

MG II TOTAL KNEE SYSTEM STEMMED TIBIAL BASEPLATE COMPONENTS

K-Number: K050723 · 2005-04-20

ApplicantZimmer, Inc.
Decision Date2005-04-20
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MG II TOTAL KNEE SYSTEM STEMMED TIBIAL BASEPLATE COMPONENTS is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 2005-04-20 under 510(k) number K050723. 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 MG II TOTAL KNEE SYSTEM STEMMED TIBIAL BASEPLATE COMPONENTS?

MG II TOTAL KNEE SYSTEM STEMMED TIBIAL BASEPLATE COMPONENTS is a medical device that received FDA 510(k) clearance on 2005-04-20. The listed applicant is Zimmer, Inc.. The 510(k) number is K050723.

When did MG II TOTAL KNEE SYSTEM STEMMED TIBIAL BASEPLATE COMPONENTS receive FDA 510(k) clearance?

MG II TOTAL KNEE SYSTEM STEMMED TIBIAL BASEPLATE COMPONENTS received FDA 510(k) clearance on 2005-04-20, under 510(k) number K050723.

Who is the listed applicant for MG II TOTAL KNEE SYSTEM STEMMED TIBIAL BASEPLATE COMPONENTS?

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

What is the FDA product code for MG II TOTAL KNEE SYSTEM STEMMED TIBIAL BASEPLATE COMPONENTS?

The FDA product code for MG II TOTAL KNEE SYSTEM STEMMED TIBIAL BASEPLATE COMPONENTS is JWH.

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Other records listing Zimmer, 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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