CoRoent 5113400: FDA 510(k) K231735, NuVasive, LLC

Regulatory status

as of registry sync 22 Oct 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	NumberK170962	Date26 Jun 2017Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK163707	Date1 May 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	NumberK160916	Date28 Jun 2016Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK153419	Date13 Apr 2016Decided	StatusActive
United States	GUDID listing	Number00887517574190 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	NumberK141896	Date20 Nov 2014Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK140319	Date9 Oct 2014Decided	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	NumberK120918	Date28 Jun 2012Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00887517574190
FDA 510(k) database 510(k) number K231735
FDA 510(k) database 510(k) number K170962
FDA 510(k) database 510(k) number K163707
FDA 510(k) database 510(k) number K161230
FDA 510(k) database 510(k) number K160916
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 K141896

Across registries

2 registries list this device

FDA 510(k) K231735 decided 11 Jul 2023 Active· +12 more in the status table
FDA GUDID UDI-DI 00887517574190 listed 24 Oct 2015 Listed

Timeline

14 dated events

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 00887517574190
13 Apr 2016 Cleared FDA 510(k) K153419
28 Jun 2016 Cleared FDA 510(k) K160916
25 Aug 2016 Cleared FDA 510(k) K161230
1 May 2017 Cleared FDA 510(k) K163707
26 Jun 2017 Cleared FDA 510(k) K170962
11 Jul 2023 Cleared FDA 510(k) K231735

4 earlier events 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: 5113400

Primary DI / UDI-DI: 00887517574190
510(k) Number: K120918
K140319
K140659
K141665
K141896
K150994
K151472
K153419
K160916
K161230
K163707
K170962
K231735
FDA product code: MQP, MAX, OVD, PHM, ODP
GMDN term: Metallic spinal interbody fusion cage

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

Sterilisation method: Moist Heat or Steam Sterilization

Category: Metallic spinal interbody fusion cage

Cleared under the same submission (K120918)

and 8 more cleared under K120918

Cleared under the same submission (K140319)

and 8 more cleared under K140319

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

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Other devices filed under Metallic spinal interbody fusion cage.

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Properties

Sterilise before use
Implantable
Prescription use
Lot / batch number

Other properties (11, all answered No)