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CD HORIZON® SOLERA® Spinal System 654100090

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 Number00643169749795 UDI-DI Date3 Feb 2018ListedStatusListed 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  • Withdrawn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
CD HORIZON® SOLERA® Spinal System
Generic Name
Bone-screw internal spinal fixation system rod
Model / Reference
654100090
Primary DI / UDI-DI
00643169749795
510(k) Number
FDA Product Code
HWE, NKB, KWP, OLO, KWQ
GMDN Term
Bone-screw internal spinal fixation system rod
Device Class
Class I
Regulation Number
878.4820, 888.3070, 888.3050, 882.4560, 888.3060
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 5.5 Millimeter

Related devices

Category: Bone-screw internal spinal fixation system rod

Cleared under the same submission (K170679)

Show all (12)

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Properties

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

Other properties (9)

  • 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