FDA.reportPublic FDA data

PMA P850035S049

Device
SpF Implantable Spinal Fusion Stimulators
Applicant
Ahp Eos Buyer, Inc.
PMA number
P850035
Supplement
S049
Product code
LOE
Decision date
2018-03-29
Classification
Stimulator, Invasive Bone Growth
Generic name
Stimulator, invasive bone growth
Approval order statement
Addition of an alternate supplier to provide laboratory services for both the SpF Implantable Spinal Fusion System and the EBI OsteoGen Implantable Bone Growth Stimulator.

Current openFDA PMA Record#

Device
SpF Implantable Spinal Fusion Stimulators
Applicant
Ahp Eos Buyer, Inc.
PMA number
P850035
Supplement
S049
Product code
LOE
Generic name
Stimulator, invasive bone growth
Decision date
2018-03-29
Decision code
OK30
Date received
2018-03-09
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of an alternate supplier to provide laboratory services for both the SpF Implantable Spinal Fusion System and the EBI OsteoGen Implantable Bone Growth Stimulator.