NDN · Class II · 21 CFR 888.3027

FDA Product Code NDN: Cement, Bone, Vertebroplasty

Leading manufacturers include Xelite Biomed , Ltd., GS Medical Co., Ltd. and Stryker Instruments.

108

Total

108

Cleared

154d

Avg days

2004

Since

Stable submission activity - 4 submissions in the last 2 years

Consistent review times: 137d avg (recent)

FDA 510(k) Cleared Cement, Bone, Vertebroplasty Devices (Product Code NDN)

108 devices

1–24 of 108

Cleared Jan 28, 2026

XeliteMed SuperM-Fix Spinal Bone Cement

XeliteMed VertehighFix High Viscosity Spinal Bone Cement System

XeliteMed VertehighFix High Viscosity Spinal Bone Cement

Balloon Inflation System

K232842

Ningbo Hicren Biotechnology Co., Ltd.

Orthopedic · 168d

Cleared Feb 09, 2024

V-STRUT® Vertebral Implant

Renova Spine Balloon Catheter

INJECTION PIN (KIP(02031-02061) (03031-03061))

SpineJack® Expansion Kit

KYPHON VuE Bone Cement

TRACKER Plus Kyphoplasty System

SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement

SpineJack Expansion Kit

CONFIDENCE Spinal Cement System

Joline Kyphoplasty System Allevo

V-STRUT Vertebral Implant

TRACKER Kyphoplasty System

VK100 Percutaneous Vertebral Augmentation System

SpineJack Expansion Kit

SpineKure Kyphoplasty System

KYPHON HV-R Bone Cement

K180700

Medtronic Sofamor Danek USA, Inc.

Orthopedic · 63d

Cleared Feb 27, 2017

Kyphon Xpede Bone Cement

CONCORD Plus Radiopaque Bone Cement

Kyphon HV-R Bone Cement

K160983

Medtronic, Inc.

Orthopedic · 139d

About Product Code NDN - Regulatory Context

510(k) Submission Activity

108 total 510(k) submissions under product code NDN since 2004, with 108 receiving FDA clearance (average review time: 154 days).

Submission volume has remained relatively stable over the observed period, with 4 submissions in the last 24 months.

FDA 510(k) Review Time - NDN Product Code

FDA review times for NDN submissions have been consistent, averaging 137 days recently vs 155 days historically.

NDN devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →

FDA Product Code NDN: Cement, Bone, Vertebroplasty

FDA 510(k) Cleared Cement, Bone, Vertebroplasty Devices (Product Code NDN)

About Product Code NDN - Regulatory Context

510(k) Submission Activity

FDA 510(k) Review Time - NDN Product Code

Related FDA 510(k) Regulatory Insights