FDA 510(k)

TirboLOX-L Lumbar IBFD

K-Number: K180990 · 2018-08-13

Decision Date2018-08-13

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

TirboLOX-L Lumbar IBFD is a medical device manufactured by Captiva Spine, Inc.. It received FDA 510(k) clearance on 2018-08-13 under approval number K180990. 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 TirboLOX-L Lumbar IBFD?

TirboLOX-L Lumbar IBFD is a medical device that received FDA 510(k) clearance on 2018-08-13. It is manufactured by Captiva Spine, Inc.. The 510(k) number is K180990.

When was TirboLOX-L Lumbar IBFD approved by the FDA?

TirboLOX-L Lumbar IBFD received FDA 510(k) clearance on 2018-08-13, under approval number K180990.

What company makes TirboLOX-L Lumbar IBFD?

TirboLOX-L Lumbar IBFD is manufactured by Captiva Spine, Inc..

What is the FDA product code for TirboLOX-L Lumbar IBFD?

The FDA product code for TirboLOX-L Lumbar IBFD is MAX.

Other Devices by Captiva Spine, Inc.

K181229TirboLOX-C Cervical IBFD K180475CapLOX II® / TowerLOX® MIS Pedicle Screw System K193270CapLOX II®/TowerLOX® MIS Pedicle Screw System

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.