FDA 510(k) Applications for Medical Device Product Code "KIJ"
(Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment)

FDA 510(k) Number Applicant Device Name Decision Date
K960711 ACUMED, INC. ACUMED BONE GRAFT SYSTEM 05/07/1996
K970378 IMPLANT RESOURCE, INC. STRYKER 2115 REPLACEMENT BATTERY (2115) 04/30/1997
K112599 INSURGICAL LLC INSURGICAL SINGLE USE POWER EQUIPMENT 11/06/2012
K163308 JEIL MEDICAL CORPORATION SMARTO 12/27/2016
K101563 JEIL MEDICAL CORPORATION SMARTO 12/17/2010
K972367 STRYKER INSTRUMENTS STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT 09/04/1997


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