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Nex-D2 CBAEJ-10020

by Next Orthosurgical 2 variants

Nex-D2 CBAEJ-10020 is a Class II device made by Next Orthosurgical, cleared under FDA 510(k) K141291 on 26 Aug 2014 and listed in FDA GUDID since 16 Sep 2024 (UDI-DI 00840314141545), 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

510(k) K141291

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840314141545 UDI-DI Date16 Sep 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK141291 Date26 Aug 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K141291 decided 26 Aug 2014 Active
  • FDA GUDID UDI-DI 00840314141545 listed 16 Sep 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K141291
  2. Listed FDA GUDID 00840314141545

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Nex-D2
Generic name
Spinal bone screw, non-bioabsorbable
Model / Ref / Catalog
CBAEJ-10020
Primary DI / UDI-DI
00840314141545
510(k) Number
FDA product code
NKB, OSH, MNI, MNH
GMDN term
Spinal bone screw, non-bioabsorbable
Device class
Class II
Regulation number
888.3070
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 10 Millimeter
Length — 20 Millimeter

Related devices

Category: Spinal bone screw, non-bioabsorbable

Cleared under the same submission (K141291)

and 8 more cleared under K141291

Similar devices in this category

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

Other devices from Next Orthosurgical

See all devices from Next Orthosurgical →

Properties

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