PMA P790005S062

Device

EBI OsteoGen Implantable Bone Growth Stimulators

Applicant

Ahp Eos Buyer, Inc.

PMA number

P790005

Supplement

S062

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.

Summary

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