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CervAlign Anterior Cervical Plate System

FDA UDI

Class II (US FDA UDI)

by Pioneer Surgical Technology, Inc.

Identity

Trade Name
CervAlign Anterior Cervical Plate System FDA UDI
Generic Name
Spinal fixation plate, non-bioabsorbable FDA UDI
Device Name
Fixed Self Tapping Screw FDA UDI
Model / Reference
66-FST-40-20 FDA UDI
Description
Fixed Self Tapping Screw FDA UDI

Identifiers

Catalog Number
66-FST-40-20 FDA UDI
Primary DI / UDI-DI
00846468087845 FDA UDI
FDA Product Code
KWQ FDA UDI
GMDN Term
Spinal fixation plate, non-bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3060 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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
MRI Safety
MR Conditional FDA UDI

CervAlign Anterior Cervical Plate System by Pioneer Surgical Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pioneer Surgical Technology, Inc.

Sources (1)

  • FDA UDI 3a8b9386-9f12-4215-9d56-6ea6a416249f 37 fields · synced Jun 6, 2026