T2™ Spinal System 9401915

by Medtronic Sofamor Danek, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00613994676368 UDI-DI	Date27 Jul 2015Listed	StatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: T2™ Spinal System
Generic Name: Vertebral body prosthesis
Model / Reference: 9401915

Primary DI / UDI-DI: 00613994676368
510(k) Number: K131888
FDA Product Code: MQP
GMDN Term: Vertebral body prosthesis

Device Class: Class II
Regulation Number: 888.3060
GUDID distribution status: In Commercial Distribution

Sterilization Method: Moist Heat or Steam Sterilization
MRI Safety: MR Conditional

Size: Angle — 15.0 degree
Outer Diameter — 19.0 Millimeter

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Properties

Single Use
Implantable
Prescription Use
Lot / Batch Number

Other properties (10)

Sterile: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No