Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010665091

FEI Number

3010665091

Entity Name

Pantheon Spinal LLC

City/State/Country

Georgetown, TX, US

Establishment Address

40132 Industrial Park Cir Ste 103, Georgetown, TX 78626, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Pantheon Spinal LLC (Owner Number: 10045940)

Owner / Operator Contact Address

40132 Industrial Park Circle, Suite 103, Georgetown, TX 78626, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K181548

PMA Number

N/A

All Registered Proprietary Names

Yellowstone Interbody Fusion System Pantheon Spinal IBFD Channel Cervical Interbody Fusion System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2020-04-13
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2026-02-04
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2026-02-04
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2026-02-04
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2026-02-04
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2014-01-15
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2020-04-13
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2020-02-14

Official Correspondent

Dave Lamb

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Pantheon Spinal LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K223430	Life Spine, Inc.	ProLift Micro Expandable Spacer System	2023-05-04
K102293	Globus Medical, Inc.	CALIBER SPACER	2011-01-05
K193541	Nu Vasive, Incorporated	NuVasive Cohere Thoracolumbar Interbody System	2020-03-30
K080401	Advanced Medical Technologies AG	SHELL CAGE, WAVE CAGE, LOOP CAGE	2008-05-09
K200084	Zavation Medical Products, LLC	Zavation IBF System	2020-10-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0026-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S
Z-0027-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Medium 43-51mm, non-sterile, 1302-55M
Z-0028-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Long 50-65mm, non-sterile, 1302-55L
Z-0029-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector X-Long 60-75mm, non-sterile, 1302-55XL
Z-0030-2011	Zimmer Inc.	2	SpeedLink 6.0 Transverse Connector Short 39.5-44mm, non-sterile, 1304-60S

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010665091. Last updated year: 2026. Please use registration number 3010665091 when referencing this establishment in official correspondence.