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FDA 510(k)

COMPREHENSIVE REVERSE SHOULDER

K-Number: K113121 · 2011-12-16

ApplicantBiomet Manufacturing, Inc.
Decision Date2011-12-16
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COMPREHENSIVE REVERSE SHOULDER 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 2011-12-16 under 510(k) number K113121. 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 REVERSE SHOULDER?

COMPREHENSIVE REVERSE SHOULDER is a medical device that received FDA 510(k) clearance on 2011-12-16. The listed applicant is Biomet Manufacturing, Inc.. The 510(k) number is K113121.

When did COMPREHENSIVE REVERSE SHOULDER receive FDA 510(k) clearance?

COMPREHENSIVE REVERSE SHOULDER received FDA 510(k) clearance on 2011-12-16, under 510(k) number K113121.

Who is the listed applicant for COMPREHENSIVE REVERSE SHOULDER?

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 REVERSE SHOULDER?

The FDA product code for COMPREHENSIVE REVERSE SHOULDER 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.

K130390COMPREHENSIVE CONVERTIBLE GLENOIDK113271METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONSK080685HIPLOC 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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