The following data is part of a premarket notification filed by Carlsmed, Inc. with the FDA for Aprevo Transforaminal Ibf.
Device ID | K210542 |
510k Number | K210542 |
Device Name: | Aprevo Transforaminal IBF |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
Applicant | Carlsmed, Inc. 4250 Executive Sq., Ste. 675 La Jolla, CA 92037 |
Contact | Karen Liu |
Correspondent | Karen Liu Carlsmed, Inc. 4250 Executive Sq., Ste. 675 La Jolla, CA 92037 |
Product Code | MAX |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-02-24 |
Decision Date | 2021-06-30 |