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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Lima Corporate S.P.A.. It received FDA 510(k) clearance on 2019-02-16 under 510(k) 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. The listed applicant is Lima Corporate S.P.A.. The 510(k) number is K181362.

When did TEMA Elbow System receive FDA 510(k) clearance?

TEMA Elbow System received FDA 510(k) clearance on 2019-02-16, under 510(k) number K181362.

Who is the listed applicant for TEMA Elbow System?

The FDA 510(k) record lists Lima Corporate S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TEMA Elbow System?

The FDA product code for TEMA Elbow System is JDC.

Other records listing Lima Corporate S.P.A. as applicant

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Related Devices (Code: JDC)

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.

K181307Zimmer Nexel Total Elbow, Connrad/Morrey Total ElbowZimmer, Inc.K153398Comprehensive SRS/Nexel ElbowBiomet Manufacturing Corp

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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