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Titan™

FDA UDI

Class I (US FDA UDI)

by Ascension Orthopedics, Inc.

Identity

Trade Name
Titan™ FDA UDI
Generic Name
Orthopaedic implant/instrument assembling device FDA UDI
Device Name
Titan™ Total Shoulder System The anti-rotation peg holder is used to assist with the placement of the anti-rotation peg in the Titan Total Shoulder system. FDA UDI
Model / Reference
HL0920075001 FDA UDI
Description
Titan™ Total Shoulder System The anti-rotation peg holder is used to assist with the placement of the anti-rotation peg in the Titan Total Shoulder system. FDA UDI

Identifiers

Catalog Number
HDL-0920-075-001 FDA UDI
Primary DI / UDI-DI
10381780245452 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Orthopaedic implant/instrument assembling device 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic implant/instrument assembling device

Titan™ by Ascension Orthopedics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic implant/instrument assembling device.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ascension Orthopedics, Inc.

Sources (1)

  • FDA UDI 8e83e68e-9cf7-4df0-9eb1-97ab818c4ec4 37 fields · synced May 30, 2026