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FDA 510(k)

Conical Plus Implant System

K-Number: K181157 · 2019-05-24

ApplicantOsseofuse International, Inc.
Decision Date2019-05-24
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Conical Plus Implant System is a medical device manufactured by Osseofuse International, Inc.. It received FDA 510(k) clearance on 2019-05-24 under approval number K181157. 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 Conical Plus Implant System?

Conical Plus Implant System is a medical device that received FDA 510(k) clearance on 2019-05-24. It is manufactured by Osseofuse International, Inc.. The 510(k) number is K181157.

When was Conical Plus Implant System approved by the FDA?

Conical Plus Implant System received FDA 510(k) clearance on 2019-05-24, under approval number K181157.

What company makes Conical Plus Implant System?

Conical Plus Implant System is manufactured by Osseofuse International, Inc..

What is the FDA product code for Conical Plus Implant System?

The FDA product code for Conical Plus Implant System is DZE.

Related Clinical Trials

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Related PubMed Literature

PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025)

Other Devices by Osseofuse International, Inc.

K243078HexaPLUS S OneDrill Implant System

Related Devices (Code: DZE)

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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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