| 2025-08-29 |
K250335 |
IVA & AEON Cervical and Lumbar Cage System |
ODP |
Class II |
Orthopedic |
| 2023-12-13 |
K232877 |
FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C Stand Alone System |
MRW |
Unclassified |
Unknown |
| 2023-11-27 |
K233332 |
Statera-C Spinal System |
NKG |
Class II |
Orthopedic |
| 2023-10-24 |
K232586 |
Rexious Spinal Fixation System, Statera Spinal System, Statera-M Spinal System |
NKB |
Class II |
Orthopedic |
| 2023-07-16 |
K231460 |
FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, BALTEUM & BALTEUM-ONE Lumbar Plate System, and Osprey Anterior Cervical Plate System |
KWQ |
Class II |
Orthopedic |
| 2021-08-27 |
K212038 |
K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage |
ODP |
Class II |
Orthopedic |