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FDA 510(k)

TiWAVE-C™ Porous Titanium Cervical Cage

K-Number: K180401 · 2018-06-14

ApplicantKalitec Direct, LLC
Decision Date2018-06-14
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TiWAVE-C™ Porous Titanium Cervical Cage is the device name listed in this FDA 510(k) record. The listed applicant is Kalitec Direct, LLC. It received FDA 510(k) clearance on 2018-06-14 under 510(k) number K180401. 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 TiWAVE-C™ Porous Titanium Cervical Cage?

TiWAVE-C™ Porous Titanium Cervical Cage is a medical device that received FDA 510(k) clearance on 2018-06-14. The listed applicant is Kalitec Direct, LLC. The 510(k) number is K180401.

When did TiWAVE-C™ Porous Titanium Cervical Cage receive FDA 510(k) clearance?

TiWAVE-C™ Porous Titanium Cervical Cage received FDA 510(k) clearance on 2018-06-14, under 510(k) number K180401.

Who is the listed applicant for TiWAVE-C™ Porous Titanium Cervical Cage?

The FDA 510(k) record lists Kalitec Direct, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TiWAVE-C™ Porous Titanium Cervical Cage?

The FDA product code for TiWAVE-C™ Porous Titanium Cervical Cage is ODP.

Other records listing Kalitec Direct, LLC 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.

K172808CosmoLock Pedicle Screw SystemK172086Matira™ Anterior Cervical SystemK170342Ocata Anterior Cervical SystemK163471Kalitec Direct InSePtion™ MIS Fixation 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

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

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