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X0515043

by Medtronic Sofamor Danek, Inc.

X0515043 is a Class I device made by Medtronic Sofamor Danek, Inc., listed in FDA GUDID since 13 Oct 2017 (UDI-DI 00643169649477), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00643169649477 UDI-DI Date13 Oct 2017ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic name
Spinal guidewire
Model / reference
X0515043
Primary DI / UDI-DI
00643169649477
FDA product code
LXH
GMDN term
Spinal guidewire
Device class
Class I
Regulation number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Similar devices

Other devices filed under FDA product code LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT).

Other devices from Medtronic Sofamor Danek, Inc.

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Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (11, all answered No)