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Creo 5146.2918

by Globus Medical, 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 Number00889095132106 UDI-DI Date17 Oct 2015ListedStatusListed 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  • Withdrawn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
Creo
Generic Name
Trans-facet-screw internal spinal fixation system, sterile
Model / Reference
5146.2918
Primary DI / UDI-DI
00889095132106
510(k) Number
FDA Product Code
NKB, OSH, KWP, MNI, MNH, KWQ
GMDN Term
Trans-facet-screw internal spinal fixation system, sterile
Device Class
Class II
Regulation Number
888.3070, 888.3050, 888.3060
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Length — 120 Millimeter
Outer Diameter — 9.5 Millimeter
Outer Diameter — 8 Millimeter

Related devices

Category: Trans-facet-screw internal spinal fixation system, sterile

Cleared under the same submission (K143633)

Show all (12)

Other devices from Globus Medical, Inc.

See all devices from Globus Medical, Inc. →

Properties

  • Single Use
  • Lot / Batch Number

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: 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