Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Idys ALIF ZP 3DTi

K-Number: K192168 · 2019-11-04

ApplicantClariance, Sas
Decision Date2019-11-04
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Idys ALIF ZP 3DTi is the device name listed in this FDA 510(k) record. The listed applicant is Clariance, Sas. It received FDA 510(k) clearance on 2019-11-04 under 510(k) number K192168. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Idys ALIF ZP 3DTi?

Idys ALIF ZP 3DTi is a medical device that received FDA 510(k) clearance on 2019-11-04. The listed applicant is Clariance, Sas. The 510(k) number is K192168.

When did Idys ALIF ZP 3DTi receive FDA 510(k) clearance?

Idys ALIF ZP 3DTi received FDA 510(k) clearance on 2019-11-04, under 510(k) number K192168.

Who is the listed applicant for Idys ALIF ZP 3DTi?

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

What is the FDA product code for Idys ALIF ZP 3DTi?

The FDA product code for Idys ALIF ZP 3DTi is OVD.

Other records listing Clariance, Sas 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.

K202032Idys LLIF 3DTiK202956Erisma LP Navigated InstrumentsK200920Idys ALIF ZP 3DTiK191263Idys ALIF TiVacK183259Idys™ TLIF TiVacK172465Idys™ TLIF 3DTi Cages

View all 11 devices →

Related Devices (Code: OVD)

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.

K261408SABER-XA SystemElevation SpineK261809Interwedge® Standalone LateralFoundation Surgical GroupK261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc.K260810Anteralign LS coverplateTyber Medical, LLCK254202MectaLIF 3D Metal AnteriorMedacta International S.A.K253401SCRIPT™ Implant SystemGlobus Medical, 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.

↑