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FDA 510(k)

Comprehensive Vault Reconstruction System

K-Number: K202232 · 2021-02-19

ApplicantBiomet Manufacturing Corp
Decision Date2021-02-19
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Comprehensive Vault Reconstruction System is a medical device manufactured by Biomet Manufacturing Corp. It received FDA 510(k) clearance on 2021-02-19 under approval number K202232. 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 Vault Reconstruction System?

Comprehensive Vault Reconstruction System is a medical device that received FDA 510(k) clearance on 2021-02-19. It is manufactured by Biomet Manufacturing Corp. The 510(k) number is K202232.

When was Comprehensive Vault Reconstruction System approved by the FDA?

Comprehensive Vault Reconstruction System received FDA 510(k) clearance on 2021-02-19, under approval number K202232.

What company makes Comprehensive Vault Reconstruction System?

Comprehensive Vault Reconstruction System is manufactured by Biomet Manufacturing Corp.

What is the FDA product code for Comprehensive Vault Reconstruction System?

The FDA product code for Comprehensive Vault Reconstruction System is PHX.

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Related PubMed Literature

PMID: 41734979 Strategies to Increase Patients' Adherence to Digital Therapeutics for Musculoskeletal Diseases: A Narrative Review. Yonsei medical journal (2026)

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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