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FDA 510(k)

TEMA Elbow system - Line extension

K-Number: K222807 · 2022-10-26

ApplicantLima Corporate S.P.A.
Decision Date2022-10-26
Product CodeJDB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TEMA Elbow system - Line extension 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 2022-10-26 under 510(k) number K222807. The device is classified under product code JDB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEMA Elbow system - Line extension?

TEMA Elbow system - Line extension is a medical device that received FDA 510(k) clearance on 2022-10-26. The listed applicant is Lima Corporate S.P.A.. The 510(k) number is K222807.

When did TEMA Elbow system - Line extension receive FDA 510(k) clearance?

TEMA Elbow system - Line extension received FDA 510(k) clearance on 2022-10-26, under 510(k) number K222807.

Who is the listed applicant for TEMA Elbow system - Line extension?

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 - Line extension?

The FDA product code for TEMA Elbow system - Line extension is JDB.

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Related Devices (Code: JDB)

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.

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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.

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