CoRoent 6790530

by NuVasive, LLC

CoRoent 6790530 is a Class II device made by NuVasive, LLC, cleared under FDA 510(k) K231735 on 11 Jul 2023 (5 earlier submissions) and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 00887517205599), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

+5 more

Trust

Source GUDID, synced 22 Oct 2026.

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	NumberK192582	Date13 Nov 2019Decided	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	NumberK161442	Date28 Sep 2016Decided	StatusActive
United States	GUDID listing	Number00887517205599 UDI-DI	Date24 Oct 2015Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK142299	Date25 Nov 2014Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK102547	Date7 Feb 2011Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00887517205599
FDA 510(k) database 510(k) number K231735
FDA 510(k) database 510(k) number K192582
FDA 510(k) database 510(k) number K170961
FDA 510(k) database 510(k) number K161442
FDA 510(k) database 510(k) number K142299
FDA 510(k) database 510(k) number K102547

Across registries

2 registries list this device

FDA 510(k) K231735 decided 11 Jul 2023 Active· +5 more in the status table
FDA GUDID UDI-DI 00887517205599 listed 24 Oct 2015 Listed

Timeline

7 dated events

7 Feb 2011 Cleared FDA 510(k) K102547
25 Nov 2014 Cleared FDA 510(k) K142299
24 Oct 2015 Listed FDA GUDID 00887517205599
28 Sep 2016 Cleared FDA 510(k) K161442
8 Jun 2017 Cleared FDA 510(k) K170961
13 Nov 2019 Cleared FDA 510(k) K192582
11 Jul 2023 Cleared FDA 510(k) K231735

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Withdrawn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: 6790530

Primary DI / UDI-DI: 00887517205599
510(k) Number: K102547
K142299
K161442
K170961
K192582
K231735
FDA product code: ODP, OVE
GMDN term: Metallic spinal interbody fusion cage

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

Sterilisation method: Moist Heat or Steam Sterilization

Similar devices in this category

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)