Comprehensive SRS/Nexel Elbow
K-Number: K153398 · 2016-02-03
ApplicantBiomet Manufacturing Corp
Decision Date2016-02-03
Product CodeJDC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Comprehensive SRS/Nexel Elbow is a medical device manufactured by Biomet Manufacturing Corp. It received FDA 510(k) clearance on 2016-02-03 under approval number K153398. The device is classified under product code JDC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Comprehensive SRS/Nexel Elbow?
Comprehensive SRS/Nexel Elbow is a medical device that received FDA 510(k) clearance on 2016-02-03. It is manufactured by Biomet Manufacturing Corp. The 510(k) number is K153398.
When was Comprehensive SRS/Nexel Elbow approved by the FDA?
Comprehensive SRS/Nexel Elbow received FDA 510(k) clearance on 2016-02-03, under approval number K153398.
What company makes Comprehensive SRS/Nexel Elbow?
Comprehensive SRS/Nexel Elbow is manufactured by Biomet Manufacturing Corp.
What is the FDA product code for Comprehensive SRS/Nexel Elbow?
The FDA product code for Comprehensive SRS/Nexel Elbow is JDC.
Other Devices by Biomet Manufacturing Corp
Related Devices (Code: JDC)
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.