CoRoent 1552253P2

by NuVasive, LLC

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

in data synced 22 Oct 2026

Documents

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00887517732767 UDI-DI	Date11 Jun 2021Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK140319	Date9 Oct 2014Decided	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: CoRoent
Generic name: Polymeric spinal interbody fusion cage
Model / reference: 1552253P2

Primary DI / UDI-DI: 00887517732767
510(k) Number: K140319
FDA product code: MAX
GMDN term: Polymeric spinal interbody fusion cage

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

Sterilisation method: Radiation Sterilization

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Properties

Supplied sterile
Sterilise before use
Single use
Implantable
Prescription use
Lot / batch number
Expiration date
Manufacturing date

Other properties (7)

Contains latex: No
Over-the-counter: No
Convenience kit: No
Combination product: No
HCT/P: No
Premarket exempt: No
Serial number: No