PMA P850035S047

Device

SPF Implantable Spinal Fusion Stimulators

Applicant

Ahp Eos Buyer, Inc.

PMA number

P850035

Supplement

S047

Product code

LOE

Decision date

2018-03-14

Classification

Stimulator, Invasive Bone Growth

Generic name

Stimulator, invasive bone growth

Approval order statement

Addition of an alternate supplier to provide clean room contract certification services and High Efficiency Particulate Air (HEPA) filter distribution services for both the SpF Implantable Spinal Fusion System and the EBI OsteoGen Implantable Bone Growth Stimulator.

Summary

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