The following data is part of a premarket notification filed by Pantheon Spinal with the FDA for Pantheon Ibfd.
Device ID | K203003 |
510k Number | K203003 |
Device Name: | Pantheon IBFD |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
Applicant | Pantheon Spinal 40132 Industrial Park Circle Suite 101 Georgetown, TX 78626 |
Contact | Dave Lamb |
Correspondent | Dave Lamb Pantheon Spinal 40132 Industrial Park Circle Suite 101 Georgetown, TX 78626 |
Product Code | MAX |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-10-01 |
Decision Date | 2021-07-07 |