Comprehensive Shoulder System
K-Number: K193038 · 2020-10-28
ApplicantBiomet Manufacturing Corp
Decision Date2020-10-28
Product CodeMBF
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Comprehensive Shoulder System is a medical device manufactured by Biomet Manufacturing Corp. It received FDA 510(k) clearance on 2020-10-28 under approval number K193038. The device is classified under product code MBF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Comprehensive Shoulder System?
Comprehensive Shoulder System is a medical device that received FDA 510(k) clearance on 2020-10-28. It is manufactured by Biomet Manufacturing Corp. The 510(k) number is K193038.
When was Comprehensive Shoulder System approved by the FDA?
Comprehensive Shoulder System received FDA 510(k) clearance on 2020-10-28, under approval number K193038.
What company makes Comprehensive Shoulder System?
Comprehensive Shoulder System is manufactured by Biomet Manufacturing Corp.
What is the FDA product code for Comprehensive Shoulder System?
The FDA product code for Comprehensive Shoulder System is MBF.
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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.