FDA.report

510(k) K223779

Device
EMPOWR™ blade stem
Applicant
Encore Medical, LLC
510(k) number
K223779
Product code
LPH
Decision
Substantially Equivalent (SESE)
Decision date
2023-02-13
Date received
2022-12-16
Regulation
888.3358
Classification name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Trey Thorsen
Address
9800 Metric Blvd. Suite 200 Austin TX US 78758 78758

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
00190446758891DJO SURGICALEncore Medical, L.P.2023-04-25
00190446758990DJO SURGICALEncore Medical, L.P.2023-04-25
00190446758983DJO SURGICALEncore Medical, L.P.2023-04-25
00190446758976DJO SURGICALEncore Medical, L.P.2023-04-25
00190446758969DJO SURGICALEncore Medical, L.P.2023-04-25
00190446758952DJO SURGICALEncore Medical, L.P.2023-04-25
00190446758945DJO SURGICALEncore Medical, L.P.2023-04-25
00190446758938DJO SURGICALEncore Medical, L.P.2023-04-25
00190446758921DJO SURGICALEncore Medical, L.P.2023-04-25
00190446758914DJO SURGICALEncore Medical, L.P.2023-04-25
00190446758907DJO SURGICALEncore Medical, L.P.2023-04-25
00190446759003DJO SURGICALEncore Medical, L.P.2023-04-25
00190446758884DJO SURGICALEncore Medical, L.P.2023-04-25
00190446758877DJO SURGICALEncore Medical, L.P.2023-04-25
00190446758860DJO SURGICALEncore Medical, L.P.2023-04-25
00190446758853DJO SURGICALEncore Medical, L.P.2023-04-25
00190446758846DJO SURGICALEncore Medical, L.P.2023-04-25
00190446758839DJO SURGICALEncore Medical, L.P.2023-04-25
00190446758822DJO SURGICALEncore Medical, L.P.2023-04-25
00190446758815DJO SURGICALEncore Medical, L.P.2023-04-25
00190446758808DJO SURGICALEncore Medical, L.P.2023-04-25
00190446758792DJO SURGICALEncore Medical, L.P.2023-04-25
00190446759133DJO SURGICALEncore Medical, L.P.2023-04-25
00190446759232DJO SURGICALEncore Medical, L.P.2023-04-25
00190446759225DJO SURGICALEncore Medical, L.P.2023-04-25
00190446759218DJO SURGICALEncore Medical, L.P.2023-04-25
00190446759201DJO SURGICALEncore Medical, L.P.2023-04-25
00190446759195DJO SURGICALEncore Medical, L.P.2023-04-25
00190446759188DJO SURGICALEncore Medical, L.P.2023-04-25
00190446759171DJO SURGICALEncore Medical, L.P.2023-04-25

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K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG2024-11-08