Creo 1156.0015

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

in data synced 23 Oct 2026

Documents

FDA submission, from GUDID

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

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00193982572976 UDI-DI	Date20 Jan 2024Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK182375	Date8 Apr 2019Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00193982572976
FDA 510(k) database 510(k) number K182375

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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Withdrawn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: 1156.0015

Primary DI / UDI-DI: 00193982572976
510(k) Number: K182375
FDA product code: KWP, NKB
GMDN term: Trans-facet-screw internal spinal fixation system, sterile

Device class: Class II
Regulation number: 888.3050, 888.3070
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

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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