SafeOp 2: Neural Informatix System

Stimulator, Electrical, Evoked Response

The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Safeop 2: Neural Informatix System.

Device ID	K213849
510k Number	K213849
Device Name:	SafeOp 2: Neural Informatix System
Classification	Stimulator, Electrical, Evoked Response
Applicant	Alphatec Spine, Inc. 1950 Camino Vida Roble Carlsbad, CA 92008
Contact	David Gramse
Correspondent	David Gramse Alphatec Spine, Inc. 1950 Camino Vida Roble Carlsbad, CA 92008
Product Code	GWF
Subsequent Product Code	ETN
Subsequent Product Code	GXY
Subsequent Product Code	GXZ
Subsequent Product Code	IKN
Subsequent Product Code	PDQ
CFR Regulation Number	882.1870 [🔎]
Decision	Substantially Equivalent (SESE)
Type	Traditional
3rd Party Reviewed	No
Combination Product	No
Date Received	2021-12-10
Decision Date	2022-03-09