Huvexel Co. , Ltd. - FDA 510(k) Cleared Devices
Recent clearances: BALTEUM - ONE™ Lumbar Plate System, Balteum™ Lumbar Plate System, AEON-C Stand Alone System
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Huvexel Co. , Ltd. Orthopedic ✕
8 devices
Cleared
Mar 25, 2022
BALTEUM - ONE™ Lumbar Plate System
Orthopedic
107d
Cleared
May 05, 2020
Balteum™ Lumbar Plate System
Orthopedic
35d
Cleared
Nov 13, 2019
AEON-C Stand Alone System
Orthopedic
162d
Cleared
Jun 28, 2018
FaSet Fixation System
Orthopedic
100d
Cleared
Apr 26, 2018
UNITY Sacroiliac Joint Fixation System
Orthopedic
206d
Cleared
Dec 08, 2017
Rexious Spinal Fixation System
Orthopedic
70d
Cleared
Nov 30, 2017
Fortis and Hana Anterior Cervical Plate System
Orthopedic
62d
Cleared
Oct 31, 2017
IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)
Orthopedic
32d