PMA P850035S042

Device: EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR
Applicant: Ahp Eos Buyer, Inc.
PMA number: P850035
Supplement: S042
Product code: LOE
Decision date: 2016-03-18
Classification: Stimulator, Invasive Bone Growth
Generic name: Stimulator, invasive bone growth
Approval order statement: Approval for the addition of the following contraindication to the labeling: “Any case where SpF Spinal Fusion Stimulators could come into contact with metallic implant components (i.e., those that contain a mixture of Titanium, Cobalt Chrome, and Stainless Steel).”

Current openFDA PMA Record#

Device: EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR
Applicant: Ahp Eos Buyer, Inc.
PMA number: P850035
Supplement: S042
Product code: LOE
Generic name: Stimulator, invasive bone growth
Decision date: 2016-03-18
Decision code: APPR
Date received: 2016-02-19
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for the addition of the following contraindication to the labeling: “Any case where SpF Spinal Fusion Stimulators could come into contact with metallic implant components (i.e., those that contain a mixture of Titanium, Cobalt Chrome, and Stainless Steel).”