510(k) Clearance

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.

ostaPek® VBR

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 and

GII: flexStaas pedicle screws 510(K) K210306.