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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, 85mm FDA UDI
Model / Reference
1202.2085S FDA UDI
Description
SI-LOK Select 10.0mm Screw, Washer, 85mm FDA UDI

Identifiers

Primary DI / UDI-DI
00889095944020 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
Length — 85 Millimeter FDA UDI
Outer Diameter — 10 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

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Manufacturer

Manufacturer
Globus Medical, Inc.

Sources (1)

  • FDA UDI 73e116e9-1ec0-4c19-b9ca-e0f56d539bad 36 fields · synced May 30, 2026