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SafeOp

FDA UDI

Class II (US FDA UDI)

by Alphatec Spine, Inc.

Identity

Trade Name
SafeOp FDA UDI
Generic Name
Neurophysiologic monitoring system FDA UDI
Device Name
AIX Windows Tablet Power Supply FDA UDI
Model / Reference
AIX11812 FDA UDI
Description
AIX Windows Tablet Power Supply FDA UDI

Identifiers

Primary DI / UDI-DI
00190376459042 FDA UDI
510(k) Number
K213849 FDA UDI
FDA Product Code
IKN FDA UDI
GXY FDA UDI
GWF FDA UDI
GXZ FDA UDI
ETN FDA UDI
PDQ FDA UDI
GMDN Term
Neurophysiologic monitoring system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.1375 FDA UDI
882.1320 FDA UDI
882.1870 FDA UDI
882.1350 FDA UDI
874.1820 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Neurophysiologic monitoring system

SafeOp by Alphatec Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Neurophysiologic monitoring system.

Cleared under the same submission

K213849 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Alphatec Spine, Inc.

Sources (1)

  • FDA UDI a8ca687f-d5fe-4c3e-bf78-bca51cc38567 35 fields · synced Jun 8, 2026