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)

CONSTRUX MINI PEEK VBR SYSTEM

K-Number: K051246 · 2005-06-14

ApplicantBlackstone Medical, Inc.
Decision Date2005-06-14
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CONSTRUX MINI PEEK VBR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Blackstone Medical, Inc.. It received FDA 510(k) clearance on 2005-06-14 under 510(k) number K051246. 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 CONSTRUX MINI PEEK VBR SYSTEM?

CONSTRUX MINI PEEK VBR SYSTEM is a medical device that received FDA 510(k) clearance on 2005-06-14. The listed applicant is Blackstone Medical, Inc.. The 510(k) number is K051246.

When did CONSTRUX MINI PEEK VBR SYSTEM receive FDA 510(k) clearance?

CONSTRUX MINI PEEK VBR SYSTEM received FDA 510(k) clearance on 2005-06-14, under 510(k) number K051246.

Who is the listed applicant for CONSTRUX MINI PEEK VBR SYSTEM?

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

What is the FDA product code for CONSTRUX MINI PEEK VBR SYSTEM?

The FDA product code for CONSTRUX MINI PEEK VBR 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 Blackstone Medical, Inc. 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.

K093926FIREBIRD SPINAL FIXATION SYSTEMK100614HALLMARK ANTERIOR CERVCIAL PLATE SYSTEM, HALLMARK FIVE-LEVEL CERVICAL PLATESK092624FIREBIRD SPINAL FIXATION SYSTEMK082797BLACKSTONE PEDICLE SCREW SYSTEMK081684BLACKSTONE PEDICLE SCREW SYSTEMK082235BLACKSTONE PILLAR XL PEEK SPACERS

View all 45 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.

↑