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FDA 510(k)

Ti3Z Cervical Interbody System

K-Number: K191354 · 2019-09-09

ApplicantZavation Medical Products, LLC
Decision Date2019-09-09
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Ti3Z Cervical Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Zavation Medical Products, LLC. It received FDA 510(k) clearance on 2019-09-09 under 510(k) number K191354. 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 Ti3Z Cervical Interbody System?

Ti3Z Cervical Interbody System is a medical device that received FDA 510(k) clearance on 2019-09-09. The listed applicant is Zavation Medical Products, LLC. The 510(k) number is K191354.

When did Ti3Z Cervical Interbody System receive FDA 510(k) clearance?

Ti3Z Cervical Interbody System received FDA 510(k) clearance on 2019-09-09, under 510(k) number K191354.

Who is the listed applicant for Ti3Z Cervical Interbody System?

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

What is the FDA product code for Ti3Z Cervical Interbody System?

The FDA product code for Ti3Z Cervical Interbody System is ODP.

Other records listing Zavation Medical Products, 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.

K253943Tiger 2 SystemK243908Tiger 2 SystemK233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF SystemK231811Zavation Connector SystemK223808Zavation Navigation Instrument SystemK230731Zavation ALIF System

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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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