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: Bone awl, reusable FDA UDI
Device Name: Punch Awl FDA UDI
Model / Reference: CP02-0102 FDA UDI
Description: Punch Awl FDA UDI

Identifiers

Catalog Number: CP02-0102 FDA UDI
Primary DI / UDI-DI: 00840273301493 FDA UDI
FDA Product Code: HWJ FDA UDI
GMDN Term: Bone awl, reusable 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Dry Heat Sterilization FDA UDI

Category: Bone awl, reusable

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 Bone awl, reusable.

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Trigen — Smith & Nephew, Inc. · Class I
Navigated Instruments — EVOLUTION SPINE, LLC · Class II
PYRENEES Cervical Plate System — K2M, INC. · Class I
Awl — SIGNATURE ORTHOPAEDICS PTY LTD · Class I
CONMED — Conmed Corporation · Class I
Sklar® — Sklar Corporation · Class I
Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Aegis Spine, Inc.

Sources (1)

FDA UDI 80b0929b-7ac5-43e2-b32b-6af4a24802df 34 fields · synced May 30, 2026