FDA.reportPublic FDA data

PMA P000054S071

Device
INFUSE™ Bone Graft
Applicant
Medtronic Sofamor Danek USA, Inc.
PMA number
P000054
Supplement
S071
Product code
MPW
Decision date
2023-10-06
Classification
Orthopedic
Generic name
Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction
Approval order statement
Replacement of the current stainless-steel AT basket/paddle with a modular polyethylene/stainless steel AT basket to improve ergonomics and reduce wear particles as a result of paddle motion at Integra LifeSciences, Building 105, of the facility in Plainsboro, NJ.

Current openFDA PMA Record#

Device
INFUSE™ Bone Graft
Applicant
Medtronic Sofamor Danek USA, Inc.
PMA number
P000054
Supplement
S071
Product code
MPW
Generic name
Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction
Decision date
2023-10-06
Decision code
OK30
Date received
2023-09-08
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Replacement of the current stainless-steel AT basket/paddle with a modular polyethylene/stainless steel AT basket to improve ergonomics and reduce wear particles as a result of paddle motion at Integra LifeSciences, Building 105, of the facility in Plainsboro, NJ.