T2 STRATOSPHERE™ Expandable Corpectomy System

FDA UDI

Class II (US FDA UDI)

by Medtronic Sofamor Danek, Inc.

Identity

Trade Name: T2 STRATOSPHERE™ Expandable Corpectomy System FDA UDI
Generic Name: Vertebral body prosthesis FDA UDI
Device Name: CENTERPIECE 436013B 13MM B-SIZE FDA UDI
Model / Reference: 436013B FDA UDI
Description: CENTERPIECE 436013B 13MM B-SIZE FDA UDI

Identifiers

Primary DI / UDI-DI: 00643169663121 FDA UDI
510(k) Number: K173125 FDA UDI
FDA Product Code: MQP FDA UDI
GMDN Term: Vertebral body prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3060 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

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

MRI Safety

MR Conditional FDA UDI

Category: Vertebral body prosthesis

T2 STRATOSPHERE™ Expandable Corpectomy System by Medtronic Sofamor Danek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vertebral body prosthesis.

CASCADIA™ Interbody System — K2M, INC. · Class II
CHESAPEAKE® Stabilization System — K2M, INC. · Class II
CASCADIA™ Interbody System — K2M, INC. · Class II
FORTIFY — GLOBUS MEDICAL, INC. · Class II
CASCADIA™ Interbody System — K2M, INC. · Class II
CAPRI™ Corpectomy Cage System — K2M, INC. · Class II
Cascadia™ Interbody System — K2M, INC. · Class II
Novel — ALPHATEC SPINE, INC. · Class II

Cleared under the same submission

K173125 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: Medtronic Sofamor Danek, Inc.

Sources (1)

FDA UDI b89cdea6-2958-475d-a811-5926ff8cd975 35 fields · synced May 30, 2026