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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 13 Results
ProductCode: PHX Applicant: EXACTECH, INC. Decision Date To: 09/29/2022
 
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exactech equinoxe small reverse shoulder glenospheres , exactech equinoxe reverse shoulder humeral liners , exactech equinoxe small reverse shoulder glenoid plates , exactech equinoxe reverse shoulder locking cap Exactech, Inc. K182536 10/12/2018
exactech equinoxe reverse shoulder 46x21mm glenosphere EXACTECH, INC. K150458 05/14/2015
equinoxe mega prosthesis EXACTECH, INC. K143659 04/09/2015
exactech equinox superior/posterior augment reverse shoulder glenoid baseplate - left & right EXACTECH, INC. K131575 07/03/2013
exactech equinoxe shoulder system torque defining screw and short replicator plate EXACTECH, INC. K121067 12/06/2012
equinoxe reverse shoulder compression screw / 38mm and 42mm glenosphere / superior augment glenoid plate, 10 degrees... EXACTECH, INC. K110708 04/01/2011
exactech equinox fixed angle replicator plate (0mm,1.5mm,4.5mm), humeral head-short (44mm,47mm), glenosphere (38mm,42mm) EXACTECH, INC. K102951 11/04/2010
exactech equinoxe, platform fracture stem EXACTECH, INC. K101909 08/02/2010
exactech equinoxe reverse shoulder system 36mm glenosphere and humeral liner EXACTECH, INC. K093275 05/27/2010
exactech equinoxe platform fracture stem and revision platform fracture stem EXACTECH, INC. K092900 01/07/2010
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