Integra® Ti6® Internal Fixation System

FDA UDI

Class II (US FDA UDI)

by Ascension Orthopedics, Inc.

Identity

Trade Name: Integra® Ti6® Internal Fixation System FDA UDI
Generic Name: Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
Device Name: The Integra Ti6 Internal Fixation System is comprised of Solid Bone screws used for bone fixation of the hand and foot following trauma or osteotomy. The titanium solid bone screws are a non-cannulated, threaded bone screw which is offered in 2.0, 2.5, 3.0, and 3.0mm diameters with lengths of 6 to 50mm. The system includes titanium and stainless steel instruments to facilitate the placement of the screws. FDA UDI
Model / Reference: TI6SOLIDIMP FDA UDI
Description: The Integra Ti6 Internal Fixation System is comprised of Solid Bone screws used for bone fixation of the hand and foot following trauma or osteotomy. The titanium solid bone screws are a non-cannulated, threaded bone screw which is offered in 2.0, 2.5, 3.0, and 3.0mm diameters with lengths of 6 to 50mm. The system includes titanium and stainless steel instruments to facilitate the placement of the screws. FDA UDI

Identifiers

Catalog Number: TI6SOLIDIMP FDA UDI
Primary DI / UDI-DI: 10381780074335 FDA UDI
510(k) Number: K060026 FDA UDI
FDA Product Code: HWC FDA UDI
GMDN Term: Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 FDA UDI
Commercial Distribution: Not 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

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

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

Cleared under the same submission

K060026 also covers:

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: Ascension Orthopedics, Inc.

Sources (1)

FDA UDI 3f9ddfb6-0ac9-4a81-aafd-8a1eb846298f 37 fields · synced Jun 8, 2026