Aries-L Lateral Lumbar Interbody System

FDA UDI

Class I (US FDA UDI)

by Osseus Fusion Systems Llc

Identity

Trade Name: Aries-L Lateral Lumbar Interbody System FDA UDI
Generic Name: Neurosurgical curette, single-use FDA UDI
Device Name: Lateral Cup Curette, Size 2, Straight FDA UDI
Model / Reference: 1450-7111 FDA UDI
Description: Lateral Cup Curette, Size 2, Straight FDA UDI

Identifiers

Catalog Number: 1450-7111 FDA UDI
Primary DI / UDI-DI: B06214507111 FDA UDI
510(k) Number: K181347 FDA UDI
FDA Product Code: FZS FDA UDI
GMDN Term: Neurosurgical curette, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 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

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Neurosurgical curette, single-use

Aries-L Lateral Lumbar Interbody System by Osseus Fusion Systems Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K181347 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 I	Pending data

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Manufacturer

Manufacturer: Osseus Fusion Systems Llc

Sources (1)

FDA UDI db1ca365-2871-45b2-9164-146eb99d3d31 35 fields · synced Jun 8, 2026