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EZ-Track CJBB161405A

by Next Orthosurgical

EZ-Track CJBB161405A is a Class II device made by Next Orthosurgical, cleared under FDA 510(k) K161608 on 30 Sep 2016 and listed in FDA GUDID since 12 Sep 2024 (UDI-DI 00840314137548), 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) K161608

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 Number00840314137548 UDI-DI Date12 Sep 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK161608 Date30 Sep 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K161608 decided 30 Sep 2016 Active
  • FDA GUDID UDI-DI 00840314137548 listed 12 Sep 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K161608
  2. Listed FDA GUDID 00840314137548

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
EZ-Track
Generic name
Polymeric spinal interbody fusion cage
Model / Ref / Catalog
CJBB161405A
Primary DI / UDI-DI
00840314137548
510(k) Number
FDA product code
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
Size
Width — 16 Millimeter
Length — 14 Millimeter
Height — 5 Millimeter
Angle — 0 degree

Related devices

Category: Polymeric spinal interbody fusion cage

Cleared under the same submission (K161608)

and 8 more cleared under K161608

Similar devices

Other devices filed under FDA product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical).

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)