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FDA 510(k)

EMPOWR Stem Extender, 50mm

K-Number: K230441 · 2023-03-17

ApplicantEncore Medical, L.P Dba Enovis
Decision Date2023-03-17
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EMPOWR Stem Extender, 50mm is the device name listed in this FDA 510(k) record. The listed applicant is Encore Medical, L.P Dba Enovis. It received FDA 510(k) clearance on 2023-03-17 under 510(k) number K230441. 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 Stem Extender, 50mm?

EMPOWR Stem Extender, 50mm is a medical device that received FDA 510(k) clearance on 2023-03-17. The listed applicant is Encore Medical, L.P Dba Enovis. The 510(k) number is K230441.

When did EMPOWR Stem Extender, 50mm receive FDA 510(k) clearance?

EMPOWR Stem Extender, 50mm received FDA 510(k) clearance on 2023-03-17, under 510(k) number K230441.

Who is the listed applicant for EMPOWR Stem Extender, 50mm?

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

What is the FDA product code for EMPOWR Stem Extender, 50mm?

The FDA product code for EMPOWR Stem Extender, 50mm is JWH.

Other records listing Encore Medical, L.P Dba Enovis 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.

K240324EMPOWR Revision Symmetric Knee ConesK230169EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert

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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