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SOVEREIGN™ Spinal System 78680818

by Medtronic Sofamor Danek, Inc.

Listed FDA GUDID listing, not in commercial distribution

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 Number00643169659063 UDI-DI Date2 Mar 2018ListedStatusListed GUDID: not 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  • Withdrawn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
SOVEREIGN™ Spinal System
Generic Name
Metal-polymer composite spinal interbody fusion cage
Model / Reference
78680818
Primary DI / UDI-DI
00643169659063
510(k) Number
FDA Product Code
OVD
GMDN Term
Metal-polymer composite spinal interbody fusion cage
Device Class
Class II
Regulation Number
888.3080
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
MRI Safety
MR Conditional
Size
Width — 27.0 Millimeter
Height — 18.0 Millimeter
Length — 37.0 Millimeter

Related devices

Category: Metal-polymer composite spinal interbody fusion cage

Cleared under the same submission (K172328)

Show all (12)

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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