Huvexel Co., Ltd.
South KoreaFDA applicant, unverified
- Devices
- 8
What Huvexel Co., Ltd. makes
Huvexel Co., Ltd. manufactures spinal fixation and stabilization systems, including anterior and posterior plating solutions for lumbar and cervical spine surgeries. Their portfolio includes standalone fixation devices, interbody cages for various spinal fusion procedures, and sacroiliac joint fixation systems. Products like the FaSet Fixation System and Rexious Spinal Fixation System are designed for internal stabilization, while the BALTEUM and Fortis plate systems target lumbar and cervical regions. The IVA Cage Ti is intended for interbody fusion across multiple spinal approaches.
Huvexel’s devices are classified under FDA Class II and Class U, with regulatory submissions recorded in the FDA’s 510(k) database. The company is based in the United States, and its products are listed under the relevant U.S. regulatory pathways for spinal fixation hardware. No additional international registries are specified in the provided data.
Catalogue
FaSet Fixation System Ref K180729
Regimes: 510(k) Registry: 510(k)BALTEUM - ONE™ Lumbar Plate System Ref K213820
Regimes: 510(k) Registry: 510(k)AEON-C Stand Alone System Ref K191477
Regimes: 510(k) Registry: 510(k)IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF) Ref K173080
Regimes: 510(k) Registry: 510(k)Fortis and Hana Anterior Cervical Plate System Ref K173099
Regimes: 510(k) Registry: 510(k)Rexious Spinal Fixation System Ref K173131
Regimes: 510(k) Registry: 510(k)UNITY Sacroiliac Joint Fixation System Ref K173201
Regimes: 510(k) Registry: 510(k)Balteum™ Lumbar Plate System Ref K200846
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Huvexel Co., Ltd. have in the registry?
The registry currently lists 8 devices for Huvexel Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Huvexel Co., Ltd.'s devices?
Among its 8 most recently registered devices, Huvexel Co., Ltd. has devices listed in FDA 510(k) (8 devices).
What risk classes do Huvexel Co., Ltd.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Huvexel Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Huvexel Co., Ltd. in the registry?
The most recently registered devices listed for Huvexel Co., Ltd. include FaSet Fixation System, BALTEUM - ONE™ Lumbar Plate System, AEON-C Stand Alone System and IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF).