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 Ant TLIF PEEK, 11x14x28mm 4° FDA UDI
Model / Reference: 5114284 FDA UDI
Description: CoRoent Ant TLIF PEEK, 11x14x28mm 4° FDA UDI

Identifiers

Primary DI / UDI-DI: 00887517564306 FDA UDI
510(k) Number: K071795 FDA UDI
K081611 FDA UDI
K140659 FDA UDI
K141665 FDA UDI
K150994 FDA UDI
K151472 FDA UDI
K153419 FDA UDI
K161230 FDA UDI
K170961 FDA UDI
K231735 FDA UDI
FDA Product Code: MQP FDA UDI
MAX FDA UDI
ODP FDA UDI
OVE FDA UDI
PHM FDA UDI
GMDN Term: Metallic spinal interbody fusion cage FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3060 FDA UDI
888.3080 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

K071795 also covers:

K081611 also covers:

K140659 also covers:

K141665 also covers:

K150994 also covers:

K151472 also covers:

K153419 also covers:

K161230 also covers:

K170961 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 81378b53-36fd-4d4b-85a4-97f77c411c1c 35 fields · synced May 30, 2026