FDA 510(k)

TirboLOX-C Cervical IBFD

K-Number: K181229 · 2018-09-19

Decision Date2018-09-19

Product CodeODP

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

TirboLOX-C Cervical IBFD is a medical device manufactured by Captiva Spine, Inc.. It received FDA 510(k) clearance on 2018-09-19 under approval number K181229. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TirboLOX-C Cervical IBFD?

TirboLOX-C Cervical IBFD is a medical device that received FDA 510(k) clearance on 2018-09-19. It is manufactured by Captiva Spine, Inc.. The 510(k) number is K181229.

When was TirboLOX-C Cervical IBFD approved by the FDA?

TirboLOX-C Cervical IBFD received FDA 510(k) clearance on 2018-09-19, under approval number K181229.

What company makes TirboLOX-C Cervical IBFD?

TirboLOX-C Cervical IBFD is manufactured by Captiva Spine, Inc..

What is the FDA product code for TirboLOX-C Cervical IBFD?

The FDA product code for TirboLOX-C Cervical IBFD is ODP.

Other Devices by Captiva Spine, Inc.

K180990TirboLOX-L Lumbar IBFD K180475CapLOX II® / TowerLOX® MIS Pedicle Screw System K193270CapLOX II®/TowerLOX® MIS Pedicle Screw System

Related Devices (Code: ODP)

K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC

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.