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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 inorganic implant inserter/extractor, reusable FDA UDI
Device Name
Titan™ Total Shoulder System The body separator is used in the removal of the proximal humeral body. FDA UDI
Model / Reference
SP0920068001 FDA UDI
Description
Titan™ Total Shoulder System The body separator is used in the removal of the proximal humeral body. FDA UDI

Identifiers

Catalog Number
SEP-0920-068-001 FDA UDI
Primary DI / UDI-DI
10381780247425 FDA UDI
FDA Product Code
HXW FDA UDI
GMDN Term
Orthopaedic inorganic implant inserter/extractor, reusable 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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic inorganic implant inserter/extractor, reusable

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

Similar devices

Also classified as Orthopaedic inorganic implant inserter/extractor, reusable.

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 a8064e9b-bdfa-483c-aa0d-996fcf74e511 37 fields · synced May 31, 2026