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FDA 510(k)

EVOLUTION SPINE Interbody System

K-Number: K223146 · 2023-02-07

ApplicantEvolution Spine
Decision Date2023-02-07
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EVOLUTION SPINE Interbody System is a medical device manufactured by Evolution Spine. It received FDA 510(k) clearance on 2023-02-07 under approval number K223146. 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 EVOLUTION SPINE Interbody System?

EVOLUTION SPINE Interbody System is a medical device that received FDA 510(k) clearance on 2023-02-07. It is manufactured by Evolution Spine. The 510(k) number is K223146.

When was EVOLUTION SPINE Interbody System approved by the FDA?

EVOLUTION SPINE Interbody System received FDA 510(k) clearance on 2023-02-07, under approval number K223146.

What company makes EVOLUTION SPINE Interbody System?

EVOLUTION SPINE Interbody System is manufactured by Evolution Spine.

What is the FDA product code for EVOLUTION SPINE Interbody System?

The FDA product code for EVOLUTION SPINE Interbody System is OVD.

Related Clinical Trials

NCT01143558 Searching for Persistence of Infection in Lyme Disease COMPLETED NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT04414280 The Impact of Hybrid Closed-loop Insulin Delivery in Type 1 Diabetes on Glycemic Control and PROMs ACTIVE_NOT_RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT06861309 Placental Imaging Techniques RECRUITING NCT07589023 A Retrospective Review: Outcomes of the REFLECT™ System for Idiopathic Scoliosis NOT_YET_RECRUITING

Related PubMed Literature

PMID: 39977258 Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table. European heart journal (2025)

Other Devices by Evolution Spine

K212405EMERGE™ Anterior Cervical Plate System K220275EMERGE Anterior Cervical Plate System K241846E3D™-C Interbody System K240368E3D™-A Interbody System K232432E3D™-A Interbody System K250167Evolution Spine Navigation Instruments

View all 8 devices →

Related Devices (Code: OVD)

K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation K161993Leva® Anterior Interbody SystemSpine Wave, Inc. K161379ELSA SpacersGlobus Medical, Inc. K161173Avenue® T TLIF CageLdr Spine USA, Inc. K161129PILLAR SA PTCOrthofix, 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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