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FDA 510(k)

Comprehensive Segmental Revision System (SRS)

K-Number: K173411 · 2018-02-08

ApplicantBiomet Manufacturing Corp
Decision Date2018-02-08
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Comprehensive Segmental Revision System (SRS) is a medical device manufactured by Biomet Manufacturing Corp. It received FDA 510(k) clearance on 2018-02-08 under approval number K173411. The device is classified under product code PHX. 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 2018-02-08. It is manufactured by Biomet Manufacturing Corp. The 510(k) number is K173411.

When was Comprehensive Segmental Revision System (SRS) approved by the FDA?

Comprehensive Segmental Revision System (SRS) received FDA 510(k) clearance on 2018-02-08, under approval number K173411.

What company makes Comprehensive Segmental Revision System (SRS)?

Comprehensive Segmental Revision System (SRS) is manufactured by Biomet Manufacturing Corp.

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

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

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Related PubMed Literature

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Other Devices by Biomet Manufacturing Corp

K152754COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS) K153558Ventix Suture Anchor K152262Ventix Knotless Anchors K152868ExpressBraid Graft Manipulation K153398Comprehensive SRS/Nexel Elbow K163651ExpressBraid Graft Manipulation

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Related Devices (Code: PHX)

K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc. K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation K152754COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS)Biomet Manufacturing Corp K152966Aequalis Fx2Tornier S.A.S. K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P. K170414Arthrex Univers Revers Apex Humeral StemsArthrex, Inc.

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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