K&J Consulting Corp.
United StatesFDA 510(k) applicant, unverified
- Devices
- 6
What K&J Consulting Corp. makes
K&J Consulting Corp. manufactures spinal fixation and interbody fusion systems, including anterior cervical and lumbar plates (e.g., FORTIS, BALTEUM, Osprey), sacroiliac and interspinous fixation devices (e.g., UNITY, Huvex), and PEEK and titanium cages for anterior, lateral, and posterior approaches (e.g., K&J IVA, AEON). Their portfolio also includes modular spinal fixation systems (e.g., Rexious, Statera) designed for cervical and lumbar stabilization.
The company’s devices are classified as Class II or Unclassified under FDA regulations, with most authorised via the 510(k) pathway. Products are listed in the FDA’s 510(k) database, and the manufacturer operates from the United States.
Catalogue
- 510(k) 510(k)
- 510(k) 510(k)
K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage Ref K212038
510(k) 510(k)IVA & AEON Cervical and Lumbar Cage System Ref K250335
510(k) 510(k)- 510(k) 510(k)
Statera-C™ Spinal System Ref K233332
510(k) 510(k)
Frequently asked questions
How many devices does K&J Consulting Corp. have in the registry?
The registry currently lists 6 devices for K&J Consulting Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list K&J Consulting Corp.'s devices?
Among its 6 most recently registered devices, K&J Consulting Corp. has devices listed in FDA 510(k) (6 devices).
What risk classes do K&J Consulting Corp.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for K&J Consulting Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from K&J Consulting Corp. in the registry?
The most recently registered devices listed for K&J Consulting Corp. include FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System, and Osprey™ Anterior Cervical Plate System, FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C™ Stand Alone System, K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage and IVA & AEON Cervical and Lumbar Cage System.