Data / Medical devices / United States / Pantheon Spinal LLC
Pantheon Spinal LLC: FDA-registered device maker in Georgetown, TX, United States, 5 510(k) clearances
Pantheon Spinal LLC is registered with the FDA (registration 3010665091) in Georgetown, TX, United States. It lists 6 device types. The FDA files 5 510(k) clearances under its listings, the newest dated July 26, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010665091
- Address
- 40132 Industrial Park Cir Ste 103, Georgetown, TX, United States, 78626
- Owner or operator
- Pantheon Spinal LLC (10045940)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- January 15, 2014
- Registered through
- 2026
- Brand names listed
- Channel Cervical Interbody Fusion System, Pantheon Spinal IBFD, Yellowstone Interbody Fusion System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Spinal Interlaminal | KWP | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Sacroiliac Joint Fixation | OUR | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Thoracolumbosacral Pedicle Screw System | NKB | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 26, 2024 | K241494 | Pantheon Pedicle Screw and Iliac Bolt Fixation System | NKB | Substantially Equivalent | Pantheon Spinal | accessdata.fda.gov |
| December 16, 2019 | K181548 | Pantheon Spinal Pontus Interbody Fusion Device | MAX | Substantially Equivalent | Pantheon Spinal | accessdata.fda.gov |
| June 20, 2017 | K163494 | Summit Spine Channel Cervical Interbody Fusion System | ODP | Substantially Equivalent | Summit Spine | accessdata.fda.gov |
| April 26, 2017 | K170572 | Summit Spine Yellowstone Lumbar Interbody Fusion System | MAX | Substantially Equivalent | Summit Spine | accessdata.fda.gov |
| April 26, 2013 | K113781 | PANTHEON SPINAL IBFD SYSTEM | MAX | Substantially Equivalent | Pantheon Spinal | accessdata.fda.gov |
Compare with other makers
- All makers of Intervertebral Fusion Device With Bone Graft, Lumbar
- All makers of Appliance, Fixation, Spinal Intervertebral Body
- All makers of Appliance, Fixation, Spinal Interlaminal
- All makers of Thoracolumbosacral Pedicle Screw System
- All makers of Sacroiliac Joint Fixation
- All makers of Intervertebral Fusion Device With Bone Graft, Cervical
Updated July 26, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.