FDA.reportPublic FDA data

PMA P850035S056

Device
SpF Implantable Spinal Fusion Stimulators
Applicant
Ahp Eos Buyer, Inc.
PMA number
P850035
Supplement
S056
Product code
LOE
Decision date
2021-02-17
Generic name
Stimulator, invasive bone growth
Approval order statement
Qualify and approve an alternate, proposed supplier to provide thermoformed PETG packaging trays and lids utilized in the final sterile pack assembly of EBI OsteoGen Surgically Implantable Bone Growth Stimulators and SpF Implantable Spinal Fusion Stimulators.

Current openFDA PMA Record#

Device
SpF Implantable Spinal Fusion Stimulators
Applicant
Ahp Eos Buyer, Inc.
PMA number
P850035
Supplement
S056
Product code
LOE
Generic name
Stimulator, invasive bone growth
Decision date
2021-02-17
Decision code
OK30
Date received
2021-01-21
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Qualify and approve an alternate, proposed supplier to provide thermoformed PETG packaging trays and lids utilized in the final sterile pack assembly of EBI OsteoGen Surgically Implantable Bone Growth Stimulators and SpF Implantable Spinal Fusion Stimulators.