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FDA 510(k)

MILLAR/GALANTE PRECOATED TOTAL KNEE

K-Number: K853661 · 1985-12-09

ApplicantZimmer, Inc.
Decision Date1985-12-09
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MILLAR/GALANTE PRECOATED TOTAL KNEE is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 1985-12-09 under 510(k) number K853661. 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 MILLAR/GALANTE PRECOATED TOTAL KNEE?

MILLAR/GALANTE PRECOATED TOTAL KNEE is a medical device that received FDA 510(k) clearance on 1985-12-09. The listed applicant is Zimmer, Inc.. The 510(k) number is K853661.

When did MILLAR/GALANTE PRECOATED TOTAL KNEE receive FDA 510(k) clearance?

MILLAR/GALANTE PRECOATED TOTAL KNEE received FDA 510(k) clearance on 1985-12-09, under 510(k) number K853661.

Who is the listed applicant for MILLAR/GALANTE PRECOATED TOTAL KNEE?

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 MILLAR/GALANTE PRECOATED TOTAL KNEE?

The FDA product code for MILLAR/GALANTE PRECOATED TOTAL KNEE is JWH.

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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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