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FDA 510(k)

Idys-C ZP 3DTi

K-Number: K212562 · 2021-10-12

ApplicantClariance, SA
Decision Date2021-10-12
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Idys-C ZP 3DTi is the device name listed in this FDA 510(k) record. The listed applicant is Clariance, SA. It received FDA 510(k) clearance on 2021-10-12 under 510(k) number K212562. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Idys-C ZP 3DTi?

Idys-C ZP 3DTi is a medical device that received FDA 510(k) clearance on 2021-10-12. The listed applicant is Clariance, SA. The 510(k) number is K212562.

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

Idys-C ZP 3DTi received FDA 510(k) clearance on 2021-10-12, under 510(k) number K212562.

Who is the listed applicant for Idys-C ZP 3DTi?

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

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

The FDA product code for Idys-C ZP 3DTi is OVE.

Other records listing Clariance, SA 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.

K243904Elegance® Anterior Cervical plateK243670Idys® LIFK241863Erisma® Lp Spinal Fixation System; Erisma® LP MISK240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemK240715Idys® C ZP 3DTiK220182Aggeris™-C

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Related Devices (Code: OVE)

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.

K261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution SpineK261279DeltaNEC Interbody SystemNexus SpineK252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.K260660SABER-C SystemElevation Spine

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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