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FDA 510(k)

ZIMMER R TOTAL SHOULDER II

K-Number: K790987 · 1979-06-22

ApplicantZimmer, Inc.
Decision Date1979-06-22
Product CodeKWT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ZIMMER R TOTAL SHOULDER II is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 1979-06-22 under 510(k) number K790987. The device is classified under product code KWT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZIMMER R TOTAL SHOULDER II?

ZIMMER R TOTAL SHOULDER II is a medical device that received FDA 510(k) clearance on 1979-06-22. The listed applicant is Zimmer, Inc.. The 510(k) number is K790987.

When did ZIMMER R TOTAL SHOULDER II receive FDA 510(k) clearance?

ZIMMER R TOTAL SHOULDER II received FDA 510(k) clearance on 1979-06-22, under 510(k) number K790987.

Who is the listed applicant for ZIMMER R TOTAL SHOULDER II?

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 ZIMMER R TOTAL SHOULDER II?

The FDA product code for ZIMMER R TOTAL SHOULDER II is KWT.

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Other records listing Zimmer, Inc. as applicant

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K262955OsseoFit Stemless Shoulder SystemK260831Z1 Hip SystemK261683Augment Off-Axis Instrument SystemK251840Zimmer® Persona® Personalized Knee SystemK260182Avenir® Müller Stem; Avenir Complete™ Hip SystemK253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)

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Related Devices (Code: KWT)

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.

K262173N22 Offset Humeral HeadShoulder Innovations, Inc.K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc.K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbHK241817InSet Total Shoulder SystemShoulder Innovations, Inc.K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH

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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