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Pantheon Spinal LLC

Matched from indexed company URL: PANTHEON SPINAL

FDA Registration(s)#

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

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
B528100418041023040EPIPHANY - CURVED RT/LT RASP 18MM5122154888INFO@PANTHEON-SPINAL.COM
B528100800001003020EPIPHANY - PSE REMOVAL TOOL5122154888INFO@PANTHEON-SPINAL.COM
B528100900001003030EPIPHANY - PSE REMOVAL TOOL5122154888INFO@PANTHEON-SPINAL.COM
B528101000000EPIPHANY - PSL INSERTER5122154888INFO@PANTHEON-SPINAL.COM

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

PMN#

GUDID#

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