Pantheon Spinal LLC
Georgetown, TX, US
Pantheon Spinal LLC appears in FDA device records in Georgetown, TX. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Pantheon Spinal LLC between 2013 and 2024. The busiest year on record is 2013, with 1. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2013 | 1 |
| 2019 | 1 |
| 2021 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K241494 | Pantheon Pedicle Screw and Iliac Bolt Fixation System | NKB | Substantially Equivalent | |
| K203003 | Pantheon IBFD | MAX | Substantially Equivalent | |
| K181548 | Pantheon Spinal Pontus Interbody Fusion Device | MAX | Substantially Equivalent | |
| K113781 | PANTHEON SPINAL IBFD SYSTEM | MAX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010665091 | 3010665091 | Pantheon Spinal LLC | 40132 Industrial Park Cir Ste 103, Georgetown, TX 78626 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain