3DP Lumbar Interbody System

FDA UDI

Class II (US FDA UDI)

by Genesys Orthopedics Systems LLC

Identity

Trade Name: 3DP Lumbar Interbody System FDA UDI
Generic Name: Orthopaedic cement restrictor sizer FDA UDI
Device Name: LLIF Ingot Trial, Medium 8mm x 15-Degree FDA UDI
Model / Reference: 1 FDA UDI
Description: LLIF Ingot Trial, Medium 8mm x 15-Degree FDA UDI

Identifiers

Catalog Number: GLL102-M0815 FDA UDI
Primary DI / UDI-DI: M719GLL102M08150 FDA UDI
FDA Product Code: ODP FDA UDI
MQP FDA UDI
MAX FDA UDI
GMDN Term: Orthopaedic cement restrictor sizer 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

FDA UDI

Single Use

Yes

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

Dimensions & Sizes

Size: Length — 20 Millimeter FDA UDI
Angle — 6 degree FDA UDI

Category: Orthopaedic cement restrictor sizer

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

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Also classified as Orthopaedic cement restrictor sizer.

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DISTAL CANAL SIZER — Biomet Orthopedics, Inc. · Class I
DISTAL CANAL SIZER — Biomet Orthopedics, Inc. · Class I
EVOL®ha-C Cervical Interbody System — CUTTING EDGE SPINE · Class II
EVOL®ha-C Cervical Interbody System — CUTTING EDGE SPINE · Class II
Biomet® General Hip Instruments — Biomet Orthopedics, Inc. · Class I

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: Genesys Orthopedics Systems LLC

Sources (1)

FDA UDI 9d0f144f-c780-425f-a0ac-cf0a09f7a792 36 fields · synced May 30, 2026