List of relevant pre-market notifications according to section 510(k) of the Food, Drug and Cosmetic Act (FDA) for both ostaPek® cages and pedicle fixation systems.
Trabis™ cervical corpectomy cage system
Cleared by the FDA under PLR code in 2018 510(k) K173893.
Cleared by the FDA under MQP code in 2008 510(k) K072326.
ACIF cage system
Cleared by the FDA under ODP code in 2017 510(k) K173148.
ostaPek® interbody fusion cages - ALIF, PLIF, TLIF and ELIF
ALIF cage cleared by the FDA under MAX code in 2018 510(k) K181963.
GII pedicle fixation
Cleared by the FDA under codes MNH, KWP and MNI in 1998.
GII: titanium plates 510(k) K980852
GII: titanium rods 510(k) K032604
GII: ostaPek plates 510(k) K051089
GII: polyaxial screws 510(k) K083567