Aptitude Anterior Cervical Plate System

FDA UDI

Class II (US FDA UDI)

by Curiteva, LLC

Identity

Trade Name: Aptitude Anterior Cervical Plate System FDA UDI
Generic Name: Bone awl, single-use FDA UDI
Device Name: Self-Centering Awl FDA UDI
Model / Reference: C155-410 FDA UDI
Description: Self-Centering Awl FDA UDI

Identifiers

Primary DI / UDI-DI: B648C1554100 FDA UDI
510(k) Number: K181549 FDA UDI
K181562 FDA UDI
FDA Product Code: KWQ FDA UDI
GMDN Term: Bone awl, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3060 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Bone awl, single-use

Aptitude Anterior Cervical Plate System by Curiteva, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone awl, single-use.

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Nautilus NC — Life Spine, Inc. · Class II
Arthrex® — Arthrex, Inc. · Class I
Gruve — Life Spine, Inc. · Class II
aprevo® — Carlsmed, Inc. · Class I
Avitus Pilot Hole Creator, Disposable - 11mm — Avitus Orthopaedics, Inc · Class I
aprevo® — Carlsmed, Inc. · Class I

Cleared under the same submission

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 II	Pending data

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Manufacturer

Manufacturer: Curiteva, LLC

Sources (1)

FDA UDI 85012873-7985-4203-8eb3-9e44ddf87007 35 fields · synced May 30, 2026