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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceINFUSE BONE GRAFT; CLYDESDALE SPINAL SYSTEM
Generic NameFiller, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
ApplicantMedtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, TN 38132
PMA NumberP000058
Supplement NumberS062
Date Received08/31/2016
Decision Date09/29/2016
Product Code NEK 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Alternate inspection methods for the Clydesdale Spinal System 18mm implant; 2) alternate manufacturing equipment for the Clydesdale Spinal System; and 3) the option to perform some manufacturing steps for the Clydesdale Spinal System 22mm implant in-house.
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