Ti6® Internal Fixation System

FDA UDI

Class I (US FDA UDI)

by Ascension Orthopedics, Inc.

Identity

Trade Name: Ti6® Internal Fixation System FDA UDI
Generic Name: Cannulated surgical drill bit, single-use FDA UDI
Device Name: Integra® Ti6® The drill bit is a cutting tool used to create 2.5 mm cylindrical holes. FDA UDI
Model / Reference: FS2002 FDA UDI
Description: Integra® Ti6® The drill bit is a cutting tool used to create 2.5 mm cylindrical holes. FDA UDI

Identifiers

Catalog Number: FS2002 FDA UDI
Primary DI / UDI-DI: 10381780244974 FDA UDI
FDA Product Code: HTW FDA UDI
GMDN Term: Cannulated surgical drill bit, single-use 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

Yes

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

Yes

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: Cannulated surgical drill bit, single-use

Ti6® Internal Fixation System by Ascension Orthopedics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Ascension Orthopedics, Inc.

Sources (1)

FDA UDI c4c096c0-f100-402a-9762-cd801885739e 37 fields · synced Jun 1, 2026