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Creo 1067.0942

by Globus Medical, Inc.

Creo 1067.0942 is a Class II device made by Globus Medical, Inc., cleared under FDA 510(k) K124058 on 13 May 2013 and listed in FDA GUDID since 27 Oct 2015 (UDI-DI 00889095014235), active as of 22 Oct 2026.

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) K124058

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00889095014235 UDI-DI Date27 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK124058 Date13 May 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K124058 decided 13 May 2013 Active
  • FDA GUDID UDI-DI 00889095014235 listed 27 Oct 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K124058
  2. Listed FDA GUDID 00889095014235

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  • Withdrawn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
1067.0942
Primary DI / UDI-DI
00889095014235
510(k) Number
FDA product code
MNI, NKB, OSH, MNH, KWP, 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
Sterilisation method
Moist Heat or Steam Sterilization
Size
Width — 10 Millimeter

Related devices

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

Cleared under the same submission (K124058)

and 8 more cleared under K124058

Similar devices

Other devices filed under FDA product code MNI (ORTHOSIS, SPINAL PEDICLE FIXATION).

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, all answered No)