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Paeon Anterior Cervical Plate System

FDA UDI

Class I (US FDA UDI)

by Aegis Spine, Inc.

Identity

Trade Name
Paeon Anterior Cervical Plate System FDA UDI
Generic Name
General internal orthopaedic fixation system implantation kit FDA UDI
Device Name
Drill Bit 14mm FDA UDI
Model / Reference
CP02-0314 FDA UDI
Description
Drill Bit 14mm FDA UDI

Identifiers

Catalog Number
CP02-0314 FDA UDI
Primary DI / UDI-DI
00840273301547 FDA UDI
FDA Product Code
HTW FDA UDI
GMDN Term
General internal orthopaedic fixation system implantation kit FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 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

No

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
Dry Heat Sterilization FDA UDI

Category: General internal orthopaedic fixation system implantation kit

Paeon Anterior Cervical Plate System by Aegis Spine, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General internal orthopaedic fixation system implantation kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Aegis Spine, Inc.

Sources (1)

  • FDA UDI 924fff1d-a5af-4a4a-bb86-b3d498174650 34 fields · synced May 31, 2026