FDA.reportPublic FDA data

Pantheon Spinal LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30106650913010665091Pantheon Spinal LLC1N2026-01-0140132 Industrial Park Cir Ste 103 Georgetown TX US 78626

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1668271543590410K241494Pantheon Pedicle Screw and Iliac Bolt Fixation SystemNKB2024-07-26
1668271509056324K181548Pantheon Spinal Pontus Interbody Fusion DeviceMAX2019-12-16
1668271492880161K170572Summit Spine Yellowstone Lumbar Interbody Fusion SystemMAX2017-04-26
1668271483824913K163494Summit Spine Channel Cervical Interbody Fusion SystemODP2017-06-20
1668271050872059K113781PANTHEON SPINAL IBFD SYSTEMMAX2013-04-26

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MAX32019-12-16
NKB12024-07-26
ODP12017-06-20