Skip to content

CoRoent 1662333

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

None found

in data synced 22 Oct 2026

Documents

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

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK231735 Date11 Jul 2023DecidedStatusActive
United StatesGUDID listing Number00887517711748 UDI-DI Date2 Nov 2016ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • 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  • Withdrawn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
1662333
Primary DI / UDI-DI
00887517711748
FDA product code
OVE, ODP
GMDN term
Polymeric 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

Other devices from NuVasive, LLC

  • CoRoent 6791713P2

    Class II
  • CoRoent 6791712P2

    Class II
  • ReLine 3800035

    Class II
  • ReLine 3800240

    Class II
  • ReLine 3813508

    Class II
  • ReLine 3813510

    Class II

See all devices from NuVasive, LLC →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number

Other properties (10)

  • Supplied sterile: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No