Huvexel Co. , Ltd. is one of 351 FDA 510(k) medical device manufacturers from South Korea in the dataset, ranked by real submission volume.
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
Huvexel Co. , Ltd. has 8 FDA 510(k) cleared medical devices. Based in Seongnam-Si, KR.
Last cleared in 2022. Active since 2017. Primary specialty: Orthopedic.
Browse the FDA 510(k) cleared devices submitted by Huvexel Co. , Ltd. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Dio Medical Corporation and RQMIS, Inc..
FDA 510(k) Regulatory Record - Huvexel Co. , Ltd.
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