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CD HORIZON® SOLERA® Spinal System 654700045

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 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

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00763000213558 UDI-DI Date19 Oct 2020ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
CD HORIZON® SOLERA® Spinal System
Generic Name
Bone-screw internal spinal fixation system, sterile
Model / Reference
654700045
Primary DI / UDI-DI
00763000213558
510(k) Number
FDA Product Code
NKB, KWQ, HWE, KWP
GMDN Term
Bone-screw internal spinal fixation system, sterile
Device Class
Class II
Regulation Number
888.3070, 888.3060, 878.4820, 888.3050
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K201362)

Show all (12)

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Properties

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

Other properties (10)

  • 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