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FDA 510(k)

Comprehensive Segmental Revision System(SRS)

K-Number: K223631 · 2023-07-12

ApplicantBiomet Orthopedics
Decision Date2023-07-12
Product CodeKWT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Comprehensive Segmental Revision System(SRS) is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Orthopedics. It received FDA 510(k) clearance on 2023-07-12 under 510(k) number K223631. 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 Comprehensive Segmental Revision System(SRS)?

Comprehensive Segmental Revision System(SRS) is a medical device that received FDA 510(k) clearance on 2023-07-12. The listed applicant is Biomet Orthopedics. The 510(k) number is K223631.

When did Comprehensive Segmental Revision System(SRS) receive FDA 510(k) clearance?

Comprehensive Segmental Revision System(SRS) received FDA 510(k) clearance on 2023-07-12, under 510(k) number K223631.

Who is the listed applicant for Comprehensive Segmental Revision System(SRS)?

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

What is the FDA product code for Comprehensive Segmental Revision System(SRS)?

The FDA product code for Comprehensive Segmental Revision System(SRS) is KWT.

Related Clinical Trials

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.

NCT03270982Comprehensive Segmental Revision SystemACTIVE_NOT_RECRUITING

Other records listing Biomet Orthopedics as applicant

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.

K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesK243761A.L.P.S. Small Fragment Plating SystemK200196Taperloc® Complete Hip Stems

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.

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 GmbHK222482AGILON XO Shoulder SystemImplantcast GmbH

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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