Si-Lok

FDA UDI

Class II (US FDA UDI)

by Globus Medical, Inc.

Identity

Trade Name: SI-LOK FDA UDI
Generic Name: Robotic surgical navigation system FDA UDI
Device Name: Outer Sleeve, SI-LOK Select Driver, GI1 FDA UDI
Model / Reference: 6202.6650 FDA UDI
Description: Outer Sleeve, SI-LOK Select Driver, GI1 FDA UDI

Identifiers

Primary DI / UDI-DI: 00889095965568 FDA UDI
510(k) Number: K183119 FDA UDI
FDA Product Code: OLO FDA UDI
OUR FDA UDI
GMDN Term: Robotic surgical navigation system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.4560 FDA UDI
888.3040 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Robotic surgical navigation system

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

Similar devices

Also classified as Robotic surgical navigation system.

TMINI™ Navigation Console — Think Surgical Inc. · Class II
VELYS — Medos International Sàrl · Class II
Headband Reference Star - Connector — Brainlab AG · Class II
OMNIBotics — OMNIlife science, Inc. · Class II
Cardiodrive System — Stereotaxis, Inc. · Class II
ExactechGPS — Exactech, Inc. · Class II
OMNIBotics — OMNIlife science, Inc. · Class II
REMI Robotic Navigation System — Fusion Robotics, LLC · Class II

Cleared under the same submission

K183119 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Globus Medical, Inc.

Sources (1)

FDA UDI 2abd2e26-c19a-4b71-8cba-eabbbb66199f 34 fields · synced May 30, 2026