Skip to content

CoRoent 1662305

by NuVasive, LLC

CoRoent 1662305 is a Class II device made by NuVasive, LLC, cleared under FDA 510(k) K231735 on 11 Jul 2023 (3 earlier submissions) and listed in FDA GUDID since 2 Nov 2016 (UDI-DI 00887517711267), 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

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

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 Number00887517711267 UDI-DI Date2 Nov 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K231735 decided 11 Jul 2023 Active· +3 more in the status table
  • FDA GUDID UDI-DI 00887517711267 listed 2 Nov 2016 Listed

Timeline

5 dated events

  1. Cleared FDA 510(k) K161442
  2. Listed FDA GUDID 00887517711267
  3. Cleared FDA 510(k) K170961
  4. Cleared FDA 510(k) K192582
  5. Cleared FDA 510(k) K231735

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  • Withdrawn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
1662305
Primary DI / UDI-DI
00887517711267
510(k) Number
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

Related devices

Category: Polymeric spinal interbody fusion cage

Cleared under the same submission (K161442)

and 8 more cleared under K161442

Cleared under the same submission (K170961)

and 8 more cleared under K170961

Similar devices

Other devices filed under FDA product code OVE (Intervertebral fusion device with integrated fixation, cervical).

Other devices from NuVasive, LLC

  • CoRoent 6791713P2

    Class II

  • CoRoent 6791712P2

    Class II

  • ReLine 3800035

    Class II

  • ReLine 3800240

    Class II

See all devices from NuVasive, LLC →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (10, all answered No)