Titan™

FDA UDI

Class I (US FDA UDI)

by Ascension Orthopedics, Inc.

Identity

Trade Name: Titan™ FDA UDI
Generic Name: Bone cutter FDA UDI
Device Name: Titan™ Total Shoulder System The glenoid keeled punch is used to impact the bone in the glenoid fossa for proper fit of the glenoid keel trial. It can also be used to further pressurize the cement. FDA UDI
Model / Reference: PN0920062001 FDA UDI
Description: Titan™ Total Shoulder System The glenoid keeled punch is used to impact the bone in the glenoid fossa for proper fit of the glenoid keel trial. It can also be used to further pressurize the cement. FDA UDI

Identifiers

Catalog Number: PUN-0920-062-001 FDA UDI
Primary DI / UDI-DI: 10381780246725 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Bone cutter 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

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Contains Latex

FDA UDI

Prescription Use

Yes

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Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

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Lot / Batch Number

Yes

FDA UDI

Serial Number

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Expiration Date

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Manufacturing Date

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Bone cutter

Titan™ 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 c4ebaf9f-ab48-470d-8149-8e29d593ca53 37 fields · synced May 30, 2026