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FDA 510(k)

COMPREHENSIVE CONVERTIBLE GLENOID

K-Number: K130390 · 2013-10-09

ApplicantBiomet Manufacturing, Inc.
Decision Date2013-10-09
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COMPREHENSIVE CONVERTIBLE GLENOID is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Manufacturing, Inc.. It received FDA 510(k) clearance on 2013-10-09 under 510(k) number K130390. 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 CONVERTIBLE GLENOID?

COMPREHENSIVE CONVERTIBLE GLENOID is a medical device that received FDA 510(k) clearance on 2013-10-09. The listed applicant is Biomet Manufacturing, Inc.. The 510(k) number is K130390.

When did COMPREHENSIVE CONVERTIBLE GLENOID receive FDA 510(k) clearance?

COMPREHENSIVE CONVERTIBLE GLENOID received FDA 510(k) clearance on 2013-10-09, under 510(k) number K130390.

Who is the listed applicant for COMPREHENSIVE CONVERTIBLE GLENOID?

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

What is the FDA product code for COMPREHENSIVE CONVERTIBLE GLENOID?

The FDA product code for COMPREHENSIVE CONVERTIBLE GLENOID is PHX.

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Other records listing Biomet Manufacturing, Inc. 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.

K113271METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONSK113121COMPREHENSIVE REVERSE SHOULDERK080685HIPLOC COMPRESSION HIP SCREWK080088BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTSK071271BIOMET CABLE SYSTEMK070399100KGY E-POLY ACETABULAR LINERS-ADDITIONAL PROFILES

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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.

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