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Nex-D2 CBHCK-55145

by Next Orthosurgical

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

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 StatesGUDID listing Number00840314181558 UDI-DI Date17 Apr 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK141291 Date26 Aug 2014DecidedStatusActive

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  • Withdrawn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
Nex-D2
Generic name
Bone-screw internal spinal fixation system rod
Model / Ref / Catalog
CBHCK-55145
Primary DI / UDI-DI
00840314181558
510(k) Number
FDA product code
OSH, MNI, MNH, NKB
GMDN term
Bone-screw internal spinal fixation system rod
Device class
Class II
Regulation number
888.3070
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 5.5 Millimeter
Length — 145 Millimeter

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)

  • 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