PMA P850022S029

Device

Biomet OrthoPak Non-invasive Bone Growth Stimulator System; Biomet SpinalPak Non-invasive Spine Fusion Stimulator System

Applicant

Ahp Eos Buyer, Inc.

PMA number

P850022

Supplement

S029

Product code

LOF

Decision date

2018-03-30

Classification

Stimulator, Bone Growth, Non-invasive

Generic name

Stimulator, bone growth, non-invasive

Approval order statement

Qualification of an alternate-secondary, contract service provider to provide calibration, maintenance, and rental services of instrumentation and equipment used during qualification and validation activities for the EBI OsteoGen Implantable Gone Growth Stimulators, SpF Implantable Spinal Fusion Stimulators, Biomet EBI Bone Healing System, Biomet SpinalPak, and the Biomet OrthoPak.

Summary

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