← Back to catalogue

Si-Lok

FDA UDI

Class II (US FDA UDI)

by Globus Medical, Inc.

Identity

Trade Name
SI-LOK FDA UDI
Generic Name
Trans-facet-screw internal spinal fixation system, sterile FDA UDI
Device Name
SI-LOK Select 10.0mm Screw, Washer, 90mm FDA UDI
Model / Reference
1202.2090S FDA UDI
Description
SI-LOK Select 10.0mm Screw, Washer, 90mm FDA UDI

Identifiers

Primary DI / UDI-DI
00889095944037 FDA UDI
510(k) Number
K183119 FDA UDI
FDA Product Code
OUR FDA UDI
GMDN Term
Trans-facet-screw internal spinal fixation system, sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 10 Millimeter FDA UDI
Length — 90 Millimeter FDA UDI

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

Si-Lok by Globus Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Trans-facet-screw internal spinal fixation system, sterile.

Cleared under the same submission

K183119 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Globus Medical, Inc.

Sources (1)

  • FDA UDI dd65526e-655f-4f60-b198-f9df0ceade25 36 fields · synced May 30, 2026