Decision Date2019-07-18
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
FAVO S-TLIF is a medical device manufactured by Silony Medical GmbH. It received FDA 510(k) clearance on 2019-07-18 under approval number K190680. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the FAVO S-TLIF?
FAVO S-TLIF is a medical device that received FDA 510(k) clearance on 2019-07-18. It is manufactured by Silony Medical GmbH. The 510(k) number is K190680.
When was FAVO S-TLIF approved by the FDA?
FAVO S-TLIF received FDA 510(k) clearance on 2019-07-18, under approval number K190680.
What company makes FAVO S-TLIF?
FAVO S-TLIF is manufactured by Silony Medical GmbH.
What is the FDA product code for FAVO S-TLIF?
The FDA product code for FAVO S-TLIF is MAX.
Related Devices (Code: MAX)
K163180Hubble IIOrbbo Surgical, LLC
K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion SystemOrthofix, Inc.
K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL
K162103Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine Interbody Fusion System (Harrier), Choice Spine Vertebral Body Replacement System (Hawkeye)Choicespine, LP
K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.
K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.
Official Source
View on FDA Database →
Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.