Surgical Arm_S

FDA UDI

Class II (US FDA UDI)

by Mazor Robotics Ltd

Identity

Trade Name: Surgical Arm_S FDA UDI
Generic Name: Multi-purpose stereotactic surgery system FDA UDI
Model / Reference: ASM0206-03 FDA UDI

Identifiers

Catalog Number: ASM0206-03S FDA UDI
Primary DI / UDI-DI: 07290109184463 FDA UDI
510(k) Number: K200935 FDA UDI
FDA Product Code: OLO FDA UDI
LLZ FDA UDI
GMDN Term: Multi-purpose stereotactic surgery system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.4560 FDA UDI
892.2050 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

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Multi-purpose stereotactic surgery system

Surgical Arm_S by Mazor Robotics Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K200935 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: Mazor Robotics Ltd

Sources (1)

FDA UDI 01a8a9db-9346-47a6-ba22-196ed20940b1 35 fields · synced May 31, 2026