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FDA 510(k)

MG II POROUS TOTAL KNEE SYSTEM/METAL-BACK PATELLAR

K-Number: K895639 · 1990-02-08

ApplicantZimmer, Inc.
Decision Date1990-02-08
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

MG II POROUS TOTAL KNEE SYSTEM/METAL-BACK PATELLAR is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 1990-02-08 under 510(k) number K895639. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the MG II POROUS TOTAL KNEE SYSTEM/METAL-BACK PATELLAR?

MG II POROUS TOTAL KNEE SYSTEM/METAL-BACK PATELLAR is a medical device that received FDA 510(k) clearance on 1990-02-08. The listed applicant is Zimmer, Inc.. The 510(k) number is K895639.

When did MG II POROUS TOTAL KNEE SYSTEM/METAL-BACK PATELLAR receive FDA 510(k) clearance?

MG II POROUS TOTAL KNEE SYSTEM/METAL-BACK PATELLAR received FDA 510(k) clearance on 1990-02-08, under 510(k) number K895639.

Who is the listed applicant for MG II POROUS TOTAL KNEE SYSTEM/METAL-BACK PATELLAR?

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 POROUS TOTAL KNEE SYSTEM/METAL-BACK PATELLAR?

The FDA product code for MG II POROUS TOTAL KNEE SYSTEM/METAL-BACK PATELLAR 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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