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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 a medical device manufactured by Medicrea International SA. It received FDA 510(k) clearance on 2021-09-03 under approval 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. It is manufactured by Medicrea International SA. The 510(k) number is K210470.

When was C-CURVE Interbody Fusion Device approved by the FDA?

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

What company makes C-CURVE Interbody Fusion Device?

C-CURVE Interbody Fusion Device is manufactured by Medicrea International SA.

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

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

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT07600502 Establish Whether Hyperangulated Videolaryngoscopy (HAVL) Can be Used to Facilitate Tracheal Intubation Effectively and Safely in Unselected Adult Patients; Describe the Population in Whom HAVL Fails to Facilitate Tracheal Intubation Successfully, Identifying Any Contributory Characteristics. NOT_YET_RECRUITING NCT04823858 3Spine Lumbar Fusion Real World Evidence Study ACTIVE_NOT_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

Related PubMed Literature

PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

Other Devices by Medicrea International SA

K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System K160640PASS XS Spinal System K160698LigaPASS K161627PASS LP Spinal System K161149PASS OCT Spinal System K160756PASS OCT Spinal System

View all 21 devices →

Related Devices (Code: OVE)

K162531STERISPINE CCSafe Orthopaedics K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc. K160313Xenco Medical Cervical Interbody SystemXenco Medical, LLC K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, 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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