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FDA 510(k)

C-CURVE Interbody Fusion Device

K-Number: K210470 · 2021-09-03

ApplicantMedicrea International SA
Decision Date2021-09-03
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

C-CURVE Interbody Fusion Device is the device name listed in this FDA 510(k) record. The listed applicant is Medicrea International SA. It received FDA 510(k) clearance on 2021-09-03 under 510(k) number K210470. 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 C-CURVE Interbody Fusion Device?

C-CURVE Interbody Fusion Device is a medical device that received FDA 510(k) clearance on 2021-09-03. The listed applicant is Medicrea International SA. The 510(k) number is K210470.

When did C-CURVE Interbody Fusion Device receive FDA 510(k) clearance?

C-CURVE Interbody Fusion Device received FDA 510(k) clearance on 2021-09-03, under 510(k) number K210470.

Who is the listed applicant for C-CURVE Interbody Fusion Device?

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

What is the FDA product code for C-CURVE Interbody Fusion Device?

The FDA product code for C-CURVE Interbody Fusion Device is OVE.

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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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