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Creo 5067.5247

by Globus Medical, Inc.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K143633

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Overview

A comprehensive 2-3 paragraph SEO description written in clear, natural language. The device is a trans-facet-screw internal spinal fixation system, designed for the treatment of various spinal conditions.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00889095094299 UDI-DI Date29 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK143633 Date30 Jan 2015DecidedStatusActive

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  • Withdrawn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 — FDA 510(k) Active

Specification

GUDID

Trade name
Creo
Generic name
Trans-facet-screw internal spinal fixation system, sterile
Model / reference
5067.5247
Primary DI / UDI-DI
00889095094299
510(k) Number
FDA product code
KWQ, MNI, MNH, OSH, NKB, KWP
GMDN term
Trans-facet-screw internal spinal fixation system, sterile
Device class
Class II
Regulation number
888.3060, 888.3070, 888.3050
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Length — 45 Millimeter
Outer Diameter — 4 Millimeter

Other devices from Globus Medical, Inc.

See all devices from Globus Medical, Inc. →

Properties

  • Sterilise before use
  • Single use
  • Lot / batch number

Other properties (12)

  • Supplied 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