FDA.reportPublic FDA data

PMA P000058S091

Device
INFUSE™ Bone Graft/Medtronic Interbody Fusion Device
Applicant
Medtronic Sofamor Danek USA, Inc.
PMA number
P000058
Supplement
S091
Product code
NEK
Decision date
2023-10-06
Classification
Orthopedic
Generic name
Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, 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/Medtronic Interbody Fusion Device
Applicant
Medtronic Sofamor Danek USA, Inc.
PMA number
P000058
Supplement
S091
Product code
NEK
Generic name
Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, 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.