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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
Spinal implant trial FDA UDI
Device Name
20x60x12 8 degree FDA UDI
Model / Reference
1450-1242 FDA UDI
Description
20x60x12 8 degree FDA UDI

Identifiers

Catalog Number
1450-1242 FDA UDI
Primary DI / UDI-DI
B06214501242 FDA UDI
510(k) Number
K181347 FDA UDI
FDA Product Code
FZK FDA UDI
GMDN Term
Spinal implant trial FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4950 FDA UDI
Commercial Distribution
Not 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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

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

Cleared under the same submission

K181347 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Osseus Fusion Systems Llc

Sources (1)

  • FDA UDI 82736675-028d-47fd-aea9-f97ad1089dbc 36 fields · synced May 30, 2026