Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System

K-Number: K214001 · 2023-03-15

ApplicantBiomet Manufacturing Corp
Decision Date2023-03-15
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Manufacturing Corp. It received FDA 510(k) clearance on 2023-03-15 under 510(k) number K214001. 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® Shoulder System, Comprehensive® Reverse Shoulder System?

Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System is a medical device that received FDA 510(k) clearance on 2023-03-15. The listed applicant is Biomet Manufacturing Corp. The 510(k) number is K214001.

When did Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System receive FDA 510(k) clearance?

Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System received FDA 510(k) clearance on 2023-03-15, under 510(k) number K214001.

Who is the listed applicant for Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System?

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

What is the FDA product code for Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System?

The FDA product code for Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System is PHX.

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.

NCT03726554Post-Market Study of Comprehensive Reverse Augmented Glenoid and Mini Humeral Tray in Total Shoulder ArthroplastyACTIVE_NOT_RECRUITING

Other records listing Biomet Manufacturing Corp 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.

PMA P010014Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearingK230540Patient Specific Planning Solution™ 3D Bone ModelsK211729Comprehensive® Convertible Glenoid - Vivacit-E LinerK202232Comprehensive Vault Reconstruction SystemK193038Comprehensive Shoulder SystemK182516Comprehensive Nano Stemless Shoulder

View all 16 devices →

Related Devices (Code: PHX)

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.

K260556Veritas Shoulder SystemRestor3DK261683Augment Off-Axis Instrument SystemZimmer, Inc.K260102Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder SystemStryker Corporation (Tornier, Inc.)K261016MSS - Humeral reverse liners extensionMedacta International, SAK253992Veritas Reverse Total Shoulder SystemRestor3DK252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics

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.

↑