FDA 510(k)

Acapella Cervical Spacer System

K-Number: K171489 · 2017-10-23

Decision Date2017-10-23

Product CodeOVE

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Acapella Cervical Spacer System is a medical device manufactured by Choicespine, LP. It received FDA 510(k) clearance on 2017-10-23 under approval number K171489. 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 Acapella Cervical Spacer System?

Acapella Cervical Spacer System is a medical device that received FDA 510(k) clearance on 2017-10-23. It is manufactured by Choicespine, LP. The 510(k) number is K171489.

When was Acapella Cervical Spacer System approved by the FDA?

Acapella Cervical Spacer System received FDA 510(k) clearance on 2017-10-23, under approval number K171489.

What company makes Acapella Cervical Spacer System?

Acapella Cervical Spacer System is manufactured by Choicespine, LP.

What is the FDA product code for Acapella Cervical Spacer System?

The FDA product code for Acapella Cervical Spacer System is OVE.

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Other Devices by Choicespine, LP

K162103Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine Interbody Fusion System (Harrier), Choice Spine Vertebral Body Replacement System (Hawkeye) K160775Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems K153107Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine VEO Lateral Access & Interbody Fusion System, Choice Spine Interbody Fusion System K170821ChoiceSpine Proliant® Posterior Pedicle Screw and Hook Fixation System K170942The Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems K170953Tomcat Cervical Spinal System

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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.