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CervAlign Anterior Cervical Plate System

FDA UDI

Class I (US FDA UDI)

by Xtant Medical Holdings, Inc.

Identity

Trade Name
CervAlign Anterior Cervical Plate System FDA UDI
Generic Name
Device sterilization/disinfection container, reusable FDA UDI
Device Name
Screw Caddy, Cervalign FDA UDI
Model / Reference
66-SCREW-CADDY FDA UDI
Description
Screw Caddy, Cervalign FDA UDI

Identifiers

Catalog Number
66-SCREW-CADDY FDA UDI
Primary DI / UDI-DI
00810076562155 FDA UDI
FDA Product Code
LRP FDA UDI
GMDN Term
Device sterilization/disinfection container, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 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

Yes

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: Device sterilization/disinfection container, reusable

CervAlign Anterior Cervical Plate System by Xtant Medical Holdings, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Device sterilization/disinfection container, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 55a8d132-eced-44e6-bb29-7873cf7d0382 35 fields · synced Jun 8, 2026