NDN · Class II · 21 CFR 888.3027

FDA Product Code NDN: Cement, Bone, Vertebroplasty

Leading manufacturers include Stryker Instruments.

2
Total
2
Cleared
58d
Avg days
2021
Since

List of Cement, Bone, Vertebroplasty devices cleared through 510(k)

2 devices
1–2 of 2
Cleared Dec 20, 2022
SpineJack® Expansion Kit
K223294
Stryker Instruments
Orthopedic · 55d
Cleared Jun 25, 2021
SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement
K211238
Stryker Instruments
Orthopedic · 60d

How to use this database

This page lists all FDA 510(k) submissions for Cement, Bone, Vertebroplasty devices (product code NDN). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Orthopedic FDA review panel. Browse all Orthopedic devices →