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FDA 510(k)

TURON GLENOID PEGGED, E+, TURON KEELED GLENOID, E+

K-Number: K123982 · 2013-01-23

ApplicantEncore Medical L.P.
Decision Date2013-01-23
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TURON GLENOID PEGGED, E+, TURON KEELED GLENOID, E+ is the device name listed in this FDA 510(k) record. The listed applicant is Encore Medical L.P.. It received FDA 510(k) clearance on 2013-01-23 under 510(k) number K123982. The device is classified under product code KWS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TURON GLENOID PEGGED, E+, TURON KEELED GLENOID, E+?

TURON GLENOID PEGGED, E+, TURON KEELED GLENOID, E+ is a medical device that received FDA 510(k) clearance on 2013-01-23. The listed applicant is Encore Medical L.P.. The 510(k) number is K123982.

When did TURON GLENOID PEGGED, E+, TURON KEELED GLENOID, E+ receive FDA 510(k) clearance?

TURON GLENOID PEGGED, E+, TURON KEELED GLENOID, E+ received FDA 510(k) clearance on 2013-01-23, under 510(k) number K123982.

Who is the listed applicant for TURON GLENOID PEGGED, E+, TURON KEELED GLENOID, E+?

The FDA 510(k) record lists Encore Medical L.P. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TURON GLENOID PEGGED, E+, TURON KEELED GLENOID, E+?

The FDA product code for TURON GLENOID PEGGED, E+, TURON KEELED GLENOID, E+ is KWS.

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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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