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Lumbar Interbody Fusion System (OLLIF)

FDA UDI

Class II (US FDA UDI)

by Advanced Research Medical Llc

Identity

Trade Name
Lumbar Interbody Fusion System (OLLIF) FDA UDI
Generic Name
Neurosurgical microscope FDA UDI
Device Name
Lumbar Interbody Fusion System (OLLIF) Handheld Microscope - Probe Retainer FDA UDI
Model / Reference
01-14-3 FDA UDI
Description
Lumbar Interbody Fusion System (OLLIF) Handheld Microscope - Probe Retainer FDA UDI

Identifiers

Catalog Number
01-14-3 FDA UDI
Primary DI / UDI-DI
00850014575632 FDA UDI
510(k) Number
K173947 FDA UDI
FDA Product Code
MAX FDA UDI
GMDN Term
Neurosurgical microscope FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3080 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Neurosurgical microscope

Lumbar Interbody Fusion System (OLLIF) by Advanced Research Medical Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Neurosurgical microscope.

Cleared under the same submission

K173947 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Advanced Research Medical Llc

Sources (1)

  • FDA UDI 3d448bdf-f708-4bc7-bec2-7ea0199f69a4 36 fields · synced May 30, 2026