FDA 510(k)

POLYFUSE - NEUROBONE

K-Number: K111018 · 2012-02-14

Decision Date2012-02-14

Product CodeMQV

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

POLYFUSE - NEUROBONE is the device name listed in this FDA 510(k) record. The listed applicant is Atpac Medical, LLC. It received FDA 510(k) clearance on 2012-02-14 under 510(k) number K111018. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLYFUSE - NEUROBONE?

POLYFUSE - NEUROBONE is a medical device that received FDA 510(k) clearance on 2012-02-14. The listed applicant is Atpac Medical, LLC. The 510(k) number is K111018.

When did POLYFUSE - NEUROBONE receive FDA 510(k) clearance?

POLYFUSE - NEUROBONE received FDA 510(k) clearance on 2012-02-14, under 510(k) number K111018.

Who is the listed applicant for POLYFUSE - NEUROBONE?

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

What is the FDA product code for POLYFUSE - NEUROBONE?

The FDA product code for POLYFUSE - NEUROBONE is MQV.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related Devices (Code: MQV)

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.