PMA P030034S011

Device

CervicalStim

Applicant

Orthofix, Inc.

PMA number

P030034

Supplement

S011

Product code

LOF

Decision date

2018-03-07

Classification

Stimulator, Bone Growth, Non-invasive

Generic name

Stimulator, bone growth, non-invasive

Approval order statement

Approval for updates to the STIM onTrack mobile application for compatibility with Android OS. The optional mobile application is identical in functionality to the previously approved iOS version. The application is compatible with the CervicalStim Model 5505, SpinalStim Model 5212, and PhysioStim Models 5302, 5303, 5313, 5314, and 5315.

Summary

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