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CoRoent 6791615

by NuVasive, LLC

CoRoent 6791615 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 00887517341563), 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 Number00887517341563 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution

Official records

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 00887517341563 listed 24 Oct 2015 Listed

Timeline

7 dated events

  1. Cleared FDA 510(k) K102547
  2. Cleared FDA 510(k) K142299
  3. Listed FDA GUDID 00887517341563
  4. Cleared FDA 510(k) K161442
  5. Cleared FDA 510(k) K170961
  6. Cleared FDA 510(k) K192582
  7. 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  • Withdrawn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
6791615
Primary DI / UDI-DI
00887517341563
510(k) Number
FDA product code
ODP, OVE
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 (K102547)

and 8 more cleared under K102547

Cleared under the same submission (K142299)

and 8 more cleared under K142299

Similar devices

Other devices filed under FDA product code ODP (Intervertebral fusion device with bone graft, 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
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (11, all answered No)