CoRoent

FDA UDI

Class II (US FDA UDI)

by Nuvasive, Inc.

Identity

Trade Name: CoRoent FDA UDI
Generic Name: Polymeric spinal interbody fusion cage FDA UDI
Device Name: Oblique TLIF, 16x10x30mm 15° FDA UDI
Model / Reference: 5363015 FDA UDI
Description: Oblique TLIF, 16x10x30mm 15° FDA UDI

Identifiers

Primary DI / UDI-DI: 00887517603692 FDA UDI
FDA Product Code: MAX FDA UDI
MQP FDA UDI
PHM FDA UDI
OVD FDA UDI
GMDN Term: Polymeric spinal interbody fusion cage 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

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Implantable

Yes

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

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Lot / Batch Number

Yes

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Serial Number

FDA UDI

Expiration Date

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Manufacturing Date

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Polymeric spinal interbody fusion cage

CoRoent is a revolutionary intervertebral fusion device with bone graft, designed to provide stable and effective spinal bone fusion for patients suffering from degenerative disc disease. This innovative device features a unique porous and threaded design, allowing for optimal integration of bone graft and promoting long-term stability and success.

Similar devices

Also classified as Polymeric spinal interbody fusion cage.

L-Box® — Innovasis, Inc. · Class II
Novel Spinal Spacer System — ALPHATEC SPINE, INC. · Class II
S-LIFT® — SPINEFRONTIER, INC. · Class II
Peridot Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · Class II
TAURUS PEEK Cage System — Medyssey Co., Ltd. · Class II
Cross-Fuse® II PEEK IBF System — Rti Surgical, Inc. · Class II
Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
Peridot Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · Class II

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: Nuvasive, Inc.

Sources (1)

FDA UDI 5e3cedd0-07b2-49b3-b954-35aba9d594e8 34 fields · synced Jul 21, 2026