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FDA 510(k)

COMPREHENSIVE REVERSE SHOULDER - E1 POLYETHYLENE CLAIMS

K-Number: K121183 · 2012-07-26

ApplicantBiomet Corporation
Decision Date2012-07-26
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COMPREHENSIVE REVERSE SHOULDER - E1 POLYETHYLENE CLAIMS is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Corporation. It received FDA 510(k) clearance on 2012-07-26 under 510(k) number K121183. 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 - E1 POLYETHYLENE CLAIMS?

COMPREHENSIVE REVERSE SHOULDER - E1 POLYETHYLENE CLAIMS is a medical device that received FDA 510(k) clearance on 2012-07-26. The listed applicant is Biomet Corporation. The 510(k) number is K121183.

When did COMPREHENSIVE REVERSE SHOULDER - E1 POLYETHYLENE CLAIMS receive FDA 510(k) clearance?

COMPREHENSIVE REVERSE SHOULDER - E1 POLYETHYLENE CLAIMS received FDA 510(k) clearance on 2012-07-26, under 510(k) number K121183.

Who is the listed applicant for COMPREHENSIVE REVERSE SHOULDER - E1 POLYETHYLENE CLAIMS?

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

What is the FDA product code for COMPREHENSIVE REVERSE SHOULDER - E1 POLYETHYLENE CLAIMS?

The FDA product code for COMPREHENSIVE REVERSE SHOULDER - E1 POLYETHYLENE CLAIMS is PHX.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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