Comprehensive Nano Stemless Shoulder
K-Number: K182516 · 2019-04-22
ApplicantBiomet Manufacturing Corp
Decision Date2019-04-22
Product CodePKC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Comprehensive Nano Stemless Shoulder is a medical device manufactured by Biomet Manufacturing Corp. It received FDA 510(k) clearance on 2019-04-22 under approval number K182516. The device is classified under product code PKC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Comprehensive Nano Stemless Shoulder?
Comprehensive Nano Stemless Shoulder is a medical device that received FDA 510(k) clearance on 2019-04-22. It is manufactured by Biomet Manufacturing Corp. The 510(k) number is K182516.
When was Comprehensive Nano Stemless Shoulder approved by the FDA?
Comprehensive Nano Stemless Shoulder received FDA 510(k) clearance on 2019-04-22, under approval number K182516.
What company makes Comprehensive Nano Stemless Shoulder?
Comprehensive Nano Stemless Shoulder is manufactured by Biomet Manufacturing Corp.
What is the FDA product code for Comprehensive Nano Stemless Shoulder?
The FDA product code for Comprehensive Nano Stemless Shoulder is PKC.
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Related PubMed Literature
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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.