FDA.reportPublic FDA data

Axis360 Surgical, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30146398433014639843Axis360 Surgical, Inc.1Y2020-04-25170 E. Corral Ave. Suite 1 Soldotna AK US 99669

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2207771086533697K181140Axis Chena Cervical PEEK Spacer SystemODP2018-11-16
2207771712273279K180301AXIS 5.5 Lumbar Pedicle Screw SystemNKB2018-04-10
2207771773785884K173867Axis Anterior Cervical Plate SystemKWQ2018-04-05
2207771492833758
2207771607524022
2207771646139530
2207771970131921
2207771988709195

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
ODP12018-11-16
NKB12018-04-10
KWQ12018-04-05