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FDA 510(k)

TirboLOX-C Cervical IBFD

K-Number: K181229 · 2018-09-19

ApplicantCaptiva Spine, Inc.
Decision Date2018-09-19
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TirboLOX-C Cervical IBFD is the device name listed in this FDA 510(k) record. The listed applicant is Captiva Spine, Inc.. It received FDA 510(k) clearance on 2018-09-19 under 510(k) 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. The listed applicant is Captiva Spine, Inc.. The 510(k) number is K181229.

When did TirboLOX-C Cervical IBFD receive FDA 510(k) clearance?

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

Who is the listed applicant for TirboLOX-C Cervical IBFD?

The FDA 510(k) record lists Captiva Spine, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Captiva Spine, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemK180990TirboLOX-L Lumbar IBFDK180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemK160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System

Related Devices (Code: ODP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K2530413d Cage CervicalFims Co., Ltd.K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEMStryker SpineK254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLCK260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.K260850OSTEOMNI SPINAL CAGES SYSTEMOsteomni, Inc.K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, 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.

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