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6136.0209

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00889095304824 UDI-DI Date27 Feb 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  • Withdrawn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
6136.0209
Primary DI / UDI-DI
00889095304824
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
Depth — 12 Millimeter
Width — 14 Millimeter
Height — 9 Millimeter

Related devices

Category: Spinal implant trial

Other devices from Globus Medical, Inc.

See all devices from Globus Medical, Inc. →

Properties

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

Other properties (11)

  • 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