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Si-Lok 1202.1050S

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) K183119

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

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00889095943597 UDI-DI Date13 Jul 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK183119 Date6 Feb 2019DecidedStatusActive

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  • Withdrawn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
Si-Lok
Generic name
Trans-facet-screw internal spinal fixation system, sterile
Model / reference
1202.1050S
Primary DI / UDI-DI
00889095943597
510(k) Number
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
Size
Length — 50 Millimeter
Outer Diameter — 10 Millimeter

Related devices

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

Cleared under the same submission (K183119)

Show all (12)

Other devices from Globus Medical, Inc.

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Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date

Other properties (11)

  • Sterilise before use: 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
  • Manufacturing date: No