The following data is part of a premarket notification filed by Pantheon Spinal with the FDA for Pantheon Spinal Pontus Interbody Fusion Device.
Device ID | K181548 |
510k Number | K181548 |
Device Name: | Pantheon Spinal Pontus Interbody Fusion Device |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
Applicant | Pantheon Spinal 3008 Bee Cave Road, Suite 200 Austin, TX 78746 |
Contact | Bob Schultz |
Correspondent | Dave Lamb Pantheon Spinal 3008 Bee Cave Road, Suite 200 Austin, TX 78746 |
Product Code | MAX |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-06-12 |
Decision Date | 2019-12-16 |