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)

NEOSS PROACTIVE IMPLANT

K-Number: K083561 · 2009-02-11

ApplicantNeoss, Ltd.
Decision Date2009-02-11
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NEOSS PROACTIVE IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Neoss, Ltd.. It received FDA 510(k) clearance on 2009-02-11 under 510(k) number K083561. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEOSS PROACTIVE IMPLANT?

NEOSS PROACTIVE IMPLANT is a medical device that received FDA 510(k) clearance on 2009-02-11. The listed applicant is Neoss, Ltd.. The 510(k) number is K083561.

When did NEOSS PROACTIVE IMPLANT receive FDA 510(k) clearance?

NEOSS PROACTIVE IMPLANT received FDA 510(k) clearance on 2009-02-11, under 510(k) number K083561.

Who is the listed applicant for NEOSS PROACTIVE IMPLANT?

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

What is the FDA product code for NEOSS PROACTIVE IMPLANT?

The FDA product code for NEOSS PROACTIVE IMPLANT is DZE.

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 Neoss, Ltd. 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.

K211396Neoss Individual ProstheticsK113376NEOSS PROACTIVE TAPERED IMPLANTK090452NEOSS IMPLANT SYSTEM 03.25K081851NEOSS ACCESS ABUTMENTSK071838NEOSS VARIOUS TITANIUM ABUTMENTSK043195NEO IMPLANT SYSTEM

View all 7 devices →

Related Devices (Code: DZE)

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.

K261392TriActive Dental Implant SystemParagon Implant Mfg., LLCK260463ZEROS Dental Implant SystemZeros Co., Ltd.K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, 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.

↑