CoRoent Spinal Interbody Fusion Cage 5182340

Regulatory status

as of registry sync 11 Nov 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK231735	Date11 Jul 2023Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK170961	Date8 Jun 2017Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK161230	Date25 Aug 2016Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK153419	Date13 Apr 2016Decided	StatusActive
United States	GUDID listing	Number00887517567598 UDI-DI	Date24 Oct 2015Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK151472	Date10 Sep 2015Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK150994	Date17 Jun 2015Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK141665	Date13 Mar 2015Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK140659	Date26 Jun 2014Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK081611	Date2 Oct 2008Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated	NumberK071795	Date4 Dec 2007Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00887517567598
FDA 510(k) database 510(k) number K231735
FDA 510(k) database 510(k) number K170961
FDA 510(k) database 510(k) number K161230
FDA 510(k) database 510(k) number K153419
FDA 510(k) database 510(k) number K151472
FDA 510(k) database 510(k) number K150994
FDA 510(k) database 510(k) number K141665
FDA 510(k) database 510(k) number K140659
FDA 510(k) database 510(k) number K081611
FDA 510(k) database 510(k) number K071795

Across registries

2 registries list this device

FDA 510(k) K231735 decided 11 Jul 2023 Active· +9 more in the status table
FDA GUDID UDI-DI 00887517567598 listed 24 Oct 2015 Listed

Timeline

11 dated events

2 Oct 2008 Cleared FDA 510(k) K081611
26 Jun 2014 Cleared FDA 510(k) K140659
13 Mar 2015 Cleared FDA 510(k) K141665
17 Jun 2015 Cleared FDA 510(k) K150994
10 Sep 2015 Cleared FDA 510(k) K151472
24 Oct 2015 Listed FDA GUDID 00887517567598
13 Apr 2016 Cleared FDA 510(k) K153419
25 Aug 2016 Cleared FDA 510(k) K161230
8 Jun 2017 Cleared FDA 510(k) K170961
11 Jul 2023 Cleared FDA 510(k) K231735

1 earlier event are in the sections above.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: CoRoent
Generic name: Metallic spinal interbody fusion cage
Model / reference: 5182340

Primary DI / UDI-DI: 00887517567598
510(k) Number: K071795
K081611
K140659
K141665
K150994
K151472
K153419
K161230
K170961
K231735
FDA product code: MAX, MQP, OVE, PHM, ODP
GMDN term: Metallic spinal interbody fusion cage

Device class: Class II
Regulation number: 888.3080, 888.3060
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

Overview

AI-generated summary, 11 Nov 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

CoRoent 5182340 is a metallic spinal interbody fusion cage. This device is an intervertebral fusion device with bone graft, lumbar, measuring 8x12x34mm 0°. It requires sterilization before use via moist heat or steam sterilization. The device is for prescription use only and its labeling does not contain MRI safety information.

The device holds FDA Class II status. It is associated with product code MAX and regulation number 888.3080, product code MQP and regulation number 888.3060, product code OVE and regulation number 888.3080, product code PHM and regulation number 888.3080, and product code ODP and regulation number 888.3080. It received 510(k) clearances K071795, K081611, K140659, K141665, K150994, K151472, K153419, K161230, K170961, and K231735.

Category: Metallic spinal interbody fusion cage

Cleared under the same submission (K071795)

and 8 more cleared under K071795

Cleared under the same submission (K081611)

and 8 more cleared under K081611

Similar devices

Also classified as Metallic spinal interbody fusion cage.

KODIAK CERVICAL IMPLANT, 14x16mm, 10mmx6° 31104606K — MET 1 TECHNOLOGIES, LLC Class II
Peridot-PT Anterior Cervical Intervertebral body fusion system C41F-1705S — GBS Commonwealth Co., Ltd. Class II
Kyocera Medical Technologies, Inc. Tesera-k ALIF — Kyocera Medical Technologies, Inc. Class II
MectaLIF 3D 03.43.233 — Medacta International SA Class II
PILLAR TL 45-7408 — Orthofix US LLC Class II

Similar devices in this category

Other devices filed under Metallic spinal interbody fusion cage.

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Questions

AI-generated answers, 11 Nov 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

What is the CoRoent 5182340?

It is recorded under the GMDN device type "Metallic spinal interbody fusion cage", which GMDN defines as "A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD)". FDA lists it under the product name "Intervertebral Fusion Device With Bone Graft, Lumbar". It is recorded as Class II.
What are the product code and regulation of the CoRoent 5182340?

FDA records the CoRoent 5182340 under product code MAX and regulation number 888.3080.
Who makes the CoRoent 5182340?

NuVasive, LLC is the manufacturer on record for the CoRoent 5182340.

Properties

Sterilise before use
Implantable
Prescription use
Lot / batch number

Other properties (11, all answered No)