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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 25 Results
ProductCode: LPH Applicant: EXACTECH, INC. Decision Date To: 12/04/2021
 
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exactech® novation® crown cup® EXACTECH, INC. K141960 09/03/2015
alteon neck preserving femoral stem, standard offset, size 6-7; alteon neck preserving femoral stem, extended offset EXACTECH, INC. K141821 08/28/2014
alteon 6.5mm bone screws EXACTECH, INC. K141797 07/29/2014
exactech tapered wedge femoral stem EXACTECH, INC. K140674 06/30/2014
novation crown cup liners; neutral, lipped, +5mm lateralized, +5/10 degree EXACTECH, INC. K121392 01/16/2013
integrip acetabular shell, integrip revision acetabular shell EXACTECH, INC. K122798 10/11/2012
novation lpi prime femoral stem EXACTECH, INC. K121684 10/01/2012
novation integrip acetabular augments, groups 4 and 5 EXACTECH, INC. K113609 01/04/2012
novation crown cup with integrip acetabular shell, cluster-hole EXACTECH, INC. K102975 11/05/2010
exactech novation empire acetabular augment with integrip model 186-01-08/11/13, 186-02-08/11/13, 186-03-08/11/13 EXACTECH, INC. K101761 09/21/2010
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