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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 17 Results
ProductCode: LPH Applicant: ENCORE MEDICAL, L.P. Decision Date To: 06/03/2023
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empowr dual mobility metal liner, empowr dual mobility poly bearing Encore Medical, L.P. K203557 02/10/2021
djo acetabular system Encore Medical, L.P. K190057 06/07/2019
fmp extended liners Encore Medical, L.P. K172651 12/13/2017
x-alt highly cross linked acetabular liners with vitamin e, neutral, 10 degree hooded, 20 degree hooded ENCORE MEDICAL, L.P. K140130 11/06/2014
x-alt highly cross linked ve acetabular liner ENCORE MEDICAL, L.P. K130365 09/23/2013
taperfill femoral hip stem 425-31-005_017 425-41-005_019 ENCORE MEDICAL, L.P. K130099 06/21/2013
revelation porous coated hip stem, size 8 ENCORE MEDICAL, L.P. K122636 11/02/2012
linear porous coated hip stem, size 5; revelation hip stem, size 8; foundation porous press fit stem, size 8; ENCORE MEDICAL, L.P. K121024 06/19/2012
linear hip stem, size 5 ENCORE MEDICAL, L.P. K120241 02/24/2012
revelation stem, model 427-21/42-080/180 ENCORE MEDICAL, L.P. K083651 03/13/2009