T2 STRATOSPHERE™ Expandable Corpectomy System NAV4361316

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 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00643169611900 UDI-DI	Date18 Sep 2019Listed	StatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: T2 STRATOSPHERE™ Expandable Corpectomy System
Generic Name: Spinal implant trial
Model / Reference: NAV4361316

Primary DI / UDI-DI: 00643169611900
510(k) Number: K191039
FDA Product Code: OLO
GMDN Term: Spinal implant trial

Device Class: Class II
Regulation Number: 882.4560
GUDID distribution status: In Commercial Distribution

Sterilization Method: Moist Heat or Steam Sterilization

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Properties

Prescription Use
Lot / Batch Number

Other properties (12)

Sterile: No
Single Use: No
Implantable: 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