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FDA 510(k)

NON CONSTRAINED TOTAL SHOULDER SYSTEM

K-Number: K895802 · 1989-12-27

ApplicantOrthopaedic Medical Group, Inc.
Decision Date1989-12-27
Product CodeKWT
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

NON CONSTRAINED TOTAL SHOULDER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Orthopaedic Medical Group, Inc.. It received FDA 510(k) clearance on 1989-12-27 under 510(k) number K895802. The device is classified under product code KWT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the NON CONSTRAINED TOTAL SHOULDER SYSTEM?

NON CONSTRAINED TOTAL SHOULDER SYSTEM is a medical device that received FDA 510(k) clearance on 1989-12-27. The listed applicant is Orthopaedic Medical Group, Inc.. The 510(k) number is K895802.

When did NON CONSTRAINED TOTAL SHOULDER SYSTEM receive FDA 510(k) clearance?

NON CONSTRAINED TOTAL SHOULDER SYSTEM received FDA 510(k) clearance on 1989-12-27, under 510(k) number K895802.

Who is the listed applicant for NON CONSTRAINED TOTAL SHOULDER SYSTEM?

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

What is the FDA product code for NON CONSTRAINED TOTAL SHOULDER SYSTEM?

The FDA product code for NON CONSTRAINED TOTAL SHOULDER SYSTEM is KWT.

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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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