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FDA 510(k)

ChoiceSpine Blackhawk Ti Cervical Spacer System

K-Number: K223869 · 2023-09-14

ApplicantChoice Spine, LLC
Decision Date2023-09-14
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ChoiceSpine Blackhawk Ti Cervical Spacer System is a medical device manufactured by Choice Spine, LLC. It received FDA 510(k) clearance on 2023-09-14 under approval number K223869. 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 ChoiceSpine Blackhawk Ti Cervical Spacer System?

ChoiceSpine Blackhawk Ti Cervical Spacer System is a medical device that received FDA 510(k) clearance on 2023-09-14. It is manufactured by Choice Spine, LLC. The 510(k) number is K223869.

When was ChoiceSpine Blackhawk Ti Cervical Spacer System approved by the FDA?

ChoiceSpine Blackhawk Ti Cervical Spacer System received FDA 510(k) clearance on 2023-09-14, under approval number K223869.

What company makes ChoiceSpine Blackhawk Ti Cervical Spacer System?

ChoiceSpine Blackhawk Ti Cervical Spacer System is manufactured by Choice Spine, LLC.

What is the FDA product code for ChoiceSpine Blackhawk Ti Cervical Spacer System?

The FDA product code for ChoiceSpine Blackhawk Ti Cervical Spacer System is OVE.

Related Clinical Trials

NCT07606196 The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases COMPLETED NCT05489822 PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use. TERMINATED NCT07153536 Spinal Cord Stimulation Combined With Physical Therapy in Post-Stroke Upper-Limb Motor Hemiparesis RECRUITING NCT05305430 Real World Data Collection on the Synergy Cervical Disc RECRUITING NCT05880823 Post Market Data Collection Protocol to Evaluate the Performance of the Synergy Disc WITHDRAWN NCT06383962 Post-Market Data Collection to Evaluate the Performance of the Synergy Disc® RECRUITING

Other Devices by Choice Spine, LLC

K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer System Ascendant PC, ChoiceSpine Cervical Interbody Spacer System Ascendant, ChoiceSpine Cervical Spacer System Blackhawk, ChoiceSpine Intervertebral Fusion Device Octane Straight, ChoiceSpine Intervertebral Fusion Device Octane Straight PC, ChoiceSpine VEO Laterial Access & Interbody Fusion System K191367Harrier-SA Lumbar Interbody System K201643ChoiceSpine Tiger Shark Cervical Spacer System K211449Triton™ Sacroiliac Joint Fixation System K203311ChoiceSpine Blackhawk Ti Cervical Spacer System K203561ChoiceSpine Navigation System

View all 9 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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