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FDA 510(k)

COMPREHENSIVE RS SHOULDER SYSTEM

K-Number: K072804 · 2007-12-12

ApplicantBiomet Manufacturing Corp
Decision Date2007-12-12
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COMPREHENSIVE RS 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 2007-12-12 under 510(k) number K072804. 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 RS SHOULDER SYSTEM?

COMPREHENSIVE RS SHOULDER SYSTEM is a medical device that received FDA 510(k) clearance on 2007-12-12. The listed applicant is Biomet Manufacturing Corp. The 510(k) number is K072804.

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

COMPREHENSIVE RS SHOULDER SYSTEM received FDA 510(k) clearance on 2007-12-12, under 510(k) number K072804.

Who is the listed applicant for COMPREHENSIVE RS 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 RS SHOULDER SYSTEM?

The FDA product code for COMPREHENSIVE RS SHOULDER SYSTEM is PHX.

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Other records listing Biomet Manufacturing Corp as applicant

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K230540Patient Specific Planning Solution™ 3D Bone ModelsK214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemK211729Comprehensive® Convertible Glenoid - Vivacit-E LinerK202232Comprehensive Vault Reconstruction SystemK193038Comprehensive Shoulder SystemK182516Comprehensive Nano Stemless Shoulder

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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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