TEMA Elbow System
K-Number: K181362 · 2019-02-16
ApplicantLima Corporate S.P.A.
Decision Date2019-02-16
Product CodeJDC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
TEMA Elbow System is a medical device manufactured by Lima Corporate S.P.A.. It received FDA 510(k) clearance on 2019-02-16 under approval number K181362. 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 TEMA Elbow System?
TEMA Elbow System is a medical device that received FDA 510(k) clearance on 2019-02-16. It is manufactured by Lima Corporate S.P.A.. The 510(k) number is K181362.
When was TEMA Elbow System approved by the FDA?
TEMA Elbow System received FDA 510(k) clearance on 2019-02-16, under approval number K181362.
What company makes TEMA Elbow System?
TEMA Elbow System is manufactured by Lima Corporate S.P.A..
What is the FDA product code for TEMA Elbow System?
The FDA product code for TEMA Elbow System is JDC.
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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.