FDA Product Code NDN: Cement, Bone, Vertebroplasty
Leading manufacturers include Xelite Biomed , Ltd., Stryker Instruments and Ningbo Hicren Biotechnology Co., Ltd..
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
Cleared
Jan 28, 2026
XeliteMed SuperM-Fix Spinal Bone Cement
Xelite Biomed , Ltd.
Orthopedic
222d
Cleared
May 30, 2025
VCFix Spinal System
Amber Implants
Orthopedic
88d
Cleared
Apr 11, 2025
XeliteMed VertehighFix High Viscosity Spinal Bone Cement System
Xelite Biomed , Ltd.
Orthopedic
147d
Cleared
Sep 18, 2024
XeliteMed VertehighFix High Viscosity Spinal Bone Cement
Xelite Biomed , Ltd.
Orthopedic
90d
Cleared
Feb 29, 2024
Balloon Inflation System
Ningbo Hicren Biotechnology Co., Ltd.
Orthopedic
168d
Cleared
Feb 09, 2024
V-STRUT® Vertebral Implant
Hyprevention
Orthopedic
29d
Cleared
Dec 20, 2022
SpineJack® Expansion Kit
Stryker Instruments
Orthopedic
55d
Cleared
Jun 25, 2021
SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement
Stryker Instruments
Orthopedic
60d
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 Review Time
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 →