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: Spinal rongeur FDA UDI
Device Name: Lumbar Interbody Fusion System (OLLIF) Pituitary Rongeur FDA UDI
Model / Reference: 01-05 FDA UDI
Description: Lumbar Interbody Fusion System (OLLIF) Pituitary Rongeur FDA UDI

Identifiers

Catalog Number: 01-05 FDA UDI
Primary DI / UDI-DI: 00850014575670 FDA UDI
510(k) Number: K173947 FDA UDI
FDA Product Code: MAX FDA UDI
GMDN Term: Spinal rongeur 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Spinal rongeur

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

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Also classified as Spinal rongeur.

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Boss Instruments — Boss Instruments, Ltd. · Class II

Cleared under the same submission

K173947 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: Advanced Research Medical Llc

Sources (1)

FDA UDI 72b6ab1e-8b2f-49b5-829f-079614b41dca 36 fields · synced May 30, 2026