NDK · Class II · 21 CFR 888.3040

FDA Product Code NDK: System, External Fixator (with Metallic Invasive Components)

Leading manufacturers include TriMed, Inc., Christopher D. Endara and 3D Medical Concepts, LLC.

3
Total
3
Cleared
187d
Avg days
2010
Since

FDA 510(k) Cleared System, External Fixator (with Metallic Invasive Components) Devices (Product Code NDK)

3 devices
1–3 of 3
Cleared Dec 29, 2014
VECTRIX EXTERNAL FIXATOR
K140649
3D Medical Concepts, LLC
Orthopedic · 291d
Cleared Dec 20, 2012
EXTERNAL FIXATOR SYSTEM
K122208
Christopher D. Endara
Orthopedic · 148d
Cleared Sep 15, 2010
TRIMED X-FIX
K101375
TriMed, Inc.
Orthopedic · 121d

About Product Code NDK - Regulatory Context