← Back to catalogue

Sigma

FDA UDI

Class II (US FDA UDI)

by Alphatec Spine, Inc.

Identity

Trade Name
Sigma FDA UDI
Generic Name
Neurophysiologic monitoring system FDA UDI
Device Name
TERTIARY DILATOR FDA UDI
Model / Reference
250-050 FDA UDI
Description
TERTIARY DILATOR FDA UDI

Identifiers

Primary DI / UDI-DI
00190376394640 FDA UDI
510(k) Number
K191723 FDA UDI
FDA Product Code
ETN FDA UDI
PDQ FDA UDI
GMDN Term
Neurophysiologic monitoring system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.1820 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Sigma 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

K191723 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Alphatec Spine, Inc.

Sources (1)

  • FDA UDI 40f17be7-393f-4567-a237-f249f6368593 35 fields · synced Jun 8, 2026