PMA P850035S051

Device: SpF Implantable Spinal Fusion Stimulators
Applicant: Ahp Eos Buyer, Inc.
PMA number: P850035
Supplement: S051
Product code: LOE
Decision date: 2018-11-02
Classification: Stimulator, Invasive Bone Growth
Generic name: Stimulator, invasive bone growth
Approval order statement: Approval for implementation of an additional finished device cleaning process and associated new, semi- automated, PLC cleaning equipment to further ensure adequate removal of manufacturing materials and residue from finished devices has occurred through conformance to cleanliness requirements in accordance with Zimmer Biomet GES 09802 Implant Residual Materials and Endotoxin Limits.

Current openFDA PMA Record#

Device: SpF Implantable Spinal Fusion Stimulators
Applicant: Ahp Eos Buyer, Inc.
PMA number: P850035
Supplement: S051
Product code: LOE
Generic name: Stimulator, invasive bone growth
Decision date: 2018-11-02
Decision code: APPR
Date received: 2018-04-02
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for implementation of an additional finished device cleaning process and associated new, semi- automated, PLC cleaning equipment to further ensure adequate removal of manufacturing materials and residue from finished devices has occurred through conformance to cleanliness requirements in accordance with Zimmer Biomet GES 09802 Implant Residual Materials and Endotoxin Limits.