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N/A 664.511

by Globus Medical, Inc.

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

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 Number00849044031607 UDI-DI Date21 Jan 2016ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic name
Spinal implant trial
Model / reference
664.511
Primary DI / UDI-DI
00849044031607
FDA product code
LXH
GMDN term
Spinal implant trial
Device class
Class I
Regulation number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Width — 35 Millimeter
Height — 11 Millimeter
Depth — 24 Millimeter

Related devices

Category: Spinal implant trial

Other devices from Globus Medical, Inc.

See all devices from Globus Medical, Inc. →

Properties

  • Sterilise before use
  • Premarket exempt
  • Lot / batch number

Other properties (12)

  • Supplied sterile: No
  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Prescription use: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No