PMA P030034S012

Device

CervicalStim

Applicant

Orthofix, Inc.

PMA number

P030034

Supplement

S012

Product code

LOF

Decision date

2018-08-22

Classification

Stimulator, Bone Growth, Non-invasive

Generic name

Stimulator, bone growth, non-invasive

Approval order statement

Approval for two proposed alternate external power supply units for Orthofix’s currently marketed CervicalStim (Model 5505), SpinalStim (Model 5212) and PhysioStim (Models 5302, 5303, 5313, 5314L, 5314R, 5315) non-invasive Bone Growth Stimulator devices.

Summary

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