The following data is part of a premarket notification filed by Vy Spine, Llc with the FDA for Lumivy Lumbar Ibf System.
Device ID | K212930 |
510k Number | K212930 |
Device Name: | LumiVy Lumbar IBF System |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
Applicant | Vy Spine, LLC 2236 Capital Circle NE, Suite 103-1 Tallahassee, FL 32308 |
Contact | Jordan Hendrickson |
Correspondent | Jordan Hendrickson Vy Spine, LLC 2236 Capital Circle NE, Suite 103-1 Tallahassee, FL 32308 |
Product Code | MAX |
Subsequent Product Code | MQP |
Subsequent Product Code | ODP |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-09-14 |
Decision Date | 2022-02-16 |