CoRoent

FDA UDI

Class II (US FDA UDI)

by Nuvasive, Inc.

Identity

Trade Name: CoRoent FDA UDI
Generic Name: Metallic spinal interbody fusion cage FDA UDI
Device Name: CoRoent® Small, 10x13x15mm Lordotic Plus FDA UDI
Model / Reference: 6810815 FDA UDI
Description: CoRoent® Small, 10x13x15mm Lordotic Plus FDA UDI

Identifiers

Primary DI / UDI-DI: 00887517366870 FDA UDI
510(k) Number: K081611 FDA UDI
K140003 FDA UDI
K140921 FDA UDI
K142050 FDA UDI
K150362 FDA UDI
K163491 FDA UDI
K231735 FDA UDI
FDA Product Code: ODP FDA UDI
MQP FDA UDI
OVE FDA UDI
GMDN Term: Metallic 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

FDA UDI

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

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: Metallic spinal interbody fusion cage

CoRoent by Nuvasive, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Metallic spinal interbody fusion cage.

KODIAK CERVICAL IMPLANT, 14x16mm, 10mmx6° — MET 1 TECHNOLOGIES, LLC · Class II
Peridot-PT Anterior Cervical Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · Class II
Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
MectaLIF 3D — Medacta International · Class II
PILLAR TL — Orthofix US LLC · Class II
Solar™ Interbody Fusion System — Degen Medical · Class II
Peridot-TD Anterior Cervical Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · Class II
ShurFit Lumbar Interbody — Precision Spine, Inc. · Class II

Cleared under the same submission

K081611 also covers:

K140003 also covers:

K140921 also covers:

K142050 also covers:

K150362 also covers:

K163491 also covers:

K231735 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 II	Pending data

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Manufacturer

Manufacturer: Nuvasive, Inc.

Sources (1)

FDA UDI 0a1d25f3-4407-46d6-a0b1-9592cd91a0c2 35 fields · synced Jun 8, 2026