Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CHOICE SPINE VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SYSTEM

K-Number: K120570 · 2012-04-05

ApplicantChoicespine, LP
Decision Date2012-04-05
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CHOICE SPINE VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Choicespine, LP. It received FDA 510(k) clearance on 2012-04-05 under 510(k) number K120570. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHOICE SPINE VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SYSTEM?

CHOICE SPINE VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SYSTEM is a medical device that received FDA 510(k) clearance on 2012-04-05. The listed applicant is Choicespine, LP. The 510(k) number is K120570.

When did CHOICE SPINE VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SYSTEM receive FDA 510(k) clearance?

CHOICE SPINE VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SYSTEM received FDA 510(k) clearance on 2012-04-05, under 510(k) number K120570.

Who is the listed applicant for CHOICE SPINE VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SYSTEM?

The FDA 510(k) record lists Choicespine, LP as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHOICE SPINE VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SYSTEM?

The FDA product code for CHOICE SPINE VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SYSTEM is MQP.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Choicespine, LP as applicant

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.

K190227Boomerang™ Anterior Cervical Plate SystemK183397ChoiceSpine Stealth Cervical Spacer SystemK182721Choice Spine Navigation SystemK183214Raven Lumbar Plate SystemK180519HARRIER-SA™ Lumbar Interbody SystemK172816TiGer Shark™ System

View all 19 devices →

Related Devices (Code: MQP)

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.

K261810Vertiwedge® Intraosseous SystemFoundation Surgical GroupK261031POSEIDON STSignus Medinzintechnik GmbHK253158VyBrate™ VBR SystemVy Spine, LLCK241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AGK233359DOMINION Expandable Corpectomy SystemAstura Medical

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.

↑