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T2 STRATOSPHERE Expandable Corpectomy System 436125C

by Medtronic Sofamor Danek, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

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

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00643169634916 UDI-DI Date24 Aug 2019ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
T2 STRATOSPHERE Expandable Corpectomy System
Generic Name
Vertebral body prosthesis
Model / Reference
436125C
Primary DI / UDI-DI
00643169634916
510(k) Number
FDA Product Code
MQP
GMDN Term
Vertebral body prosthesis
Device Class
Class II
Regulation Number
888.3060
GUDID distribution status
In Commercial Distribution
Size
Width — 25.0 Millimeter

Related devices

Category: Vertebral body prosthesis

Cleared under the same submission (K183510)

Show all (12)

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Properties

  • Sterile
  • Implantable
  • Prescription Use
  • Lot / Batch Number

Other properties (10)

  • Single Use: 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