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3DP Lumbar Interbody

FDA UDI

Class II (US FDA UDI)

by Genesys Orthopedics Systems LLC

Identity

Trade Name
3DP Lumbar Interbody FDA UDI
Generic Name
Lumbar total intervertebral disc prosthesis FDA UDI
Device Name
LLIF Big Inserter FDA UDI
Model / Reference
1 FDA UDI
Description
LLIF Big Inserter FDA UDI

Identifiers

Catalog Number
GLL106 FDA UDI
Primary DI / UDI-DI
M719GLL1060 FDA UDI
FDA Product Code
MAX FDA UDI
MQP FDA UDI
GMDN Term
Lumbar total intervertebral disc prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3080 FDA UDI
888.3060 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

Yes

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

Category: Lumbar total intervertebral disc prosthesis

3DP Lumbar Interbody by Genesys Orthopedics Systems LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Lumbar total intervertebral disc prosthesis.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Genesys Orthopedics Systems LLC

Sources (1)

  • FDA UDI 47048bfa-9180-4c72-a9eb-c66b6beba1fe 35 fields · synced Jun 8, 2026