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FDA 510(k)

EMPOWR VVC TIBIAL INSERT

K-Number: K180930 · 2018-07-09

ApplicantEncore Medical L.P.
Decision Date2018-07-09
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EMPOWR VVC TIBIAL INSERT 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 2018-07-09 under 510(k) number K180930. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMPOWR VVC TIBIAL INSERT?

EMPOWR VVC TIBIAL INSERT is a medical device that received FDA 510(k) clearance on 2018-07-09. The listed applicant is Encore Medical L.P.. The 510(k) number is K180930.

When did EMPOWR VVC TIBIAL INSERT receive FDA 510(k) clearance?

EMPOWR VVC TIBIAL INSERT received FDA 510(k) clearance on 2018-07-09, under 510(k) number K180930.

Who is the listed applicant for EMPOWR VVC TIBIAL INSERT?

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 EMPOWR VVC TIBIAL INSERT?

The FDA product code for EMPOWR VVC TIBIAL INSERT is JWH.

Other records listing Encore Medical L.P. as applicant

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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Related Devices (Code: JWH)

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.

K261563Freedom Total Knee System (E-Poly Tibial Liners)Maxx Orthopedics, Inc.K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UCK261032NovoKnee (SteriKnee)NovoSourceK253793Materialise TKA Guide SystemMaterialise NV

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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