Si-Lok 1202.5090

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 22 Oct 2026

Documents

FDA submission, from GUDID

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

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00889095979558 UDI-DI	Date12 Jul 2019Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK183119	Date6 Feb 2019Decided	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Si-Lok
Generic name: Trans-facet-screw internal spinal fixation system, sterile
Model / reference: 1202.5090

Primary DI / UDI-DI: 00889095979558
510(k) Number: K183119
FDA product code: OUR
GMDN term: Trans-facet-screw internal spinal fixation system, sterile

Device class: Class II
Regulation number: 888.3040
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

Size: Outer Diameter — 10 Millimeter
Length — 90 Millimeter

Other devices from Globus Medical, Inc.

Cervical Artificial Discs

Class III
Anthem 2171.6509

Class II
Anthem 2171.6513

Class II
Anthem 2171.6511

Class II
Anthem 2171.6515

Class II
Anthem 2171.6517

Class II

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