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CoRoent 1662613

by NuVasive, LLC

CoRoent 1662613 is a Class II device made by NuVasive, LLC, cleared under FDA 510(k) K231735 on 11 Jul 2023 (4 earlier submissions) and listed in FDA GUDID since 23 May 2016 (UDI-DI 00887517673176), 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 Number00887517673176 UDI-DI Date23 May 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K231735 decided 11 Jul 2023 Active· +4 more in the status table
  • FDA GUDID UDI-DI 00887517673176 listed 23 May 2016 Listed

Timeline

6 dated events

  1. Cleared FDA 510(k) K142299
  2. Listed FDA GUDID 00887517673176
  3. Cleared FDA 510(k) K161442
  4. Cleared FDA 510(k) K170961
  5. Cleared FDA 510(k) K192582
  6. 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  • Withdrawn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
Spinal bone screw, non-bioabsorbable
Model / reference
1662613
Primary DI / UDI-DI
00887517673176
510(k) Number
FDA product code
OVE, ODP
GMDN term
Spinal bone screw, non-bioabsorbable
Device class
Class II
Regulation number
888.3080
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Spinal bone screw, non-bioabsorbable

Cleared under the same submission (K142299)

and 8 more cleared under K142299

Cleared under the same submission (K161442)

and 8 more cleared under K161442

Similar devices in this category

Other devices filed under Spinal bone screw, non-bioabsorbable.

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)