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FDA 510(k)

Infinity Fixation System

K-Number: K191204 · 2019-07-03

ApplicantConmed Corporation
Decision Date2019-07-03
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Infinity Fixation System is a medical device manufactured by Conmed Corporation. It received FDA 510(k) clearance on 2019-07-03 under approval number K191204. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Infinity Fixation System?

Infinity Fixation System is a medical device that received FDA 510(k) clearance on 2019-07-03. It is manufactured by Conmed Corporation. The 510(k) number is K191204.

When was Infinity Fixation System approved by the FDA?

Infinity Fixation System received FDA 510(k) clearance on 2019-07-03, under approval number K191204.

What company makes Infinity Fixation System?

Infinity Fixation System is manufactured by Conmed Corporation.

What is the FDA product code for Infinity Fixation System?

The FDA product code for Infinity Fixation System is MBI.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT06941558 The UK ADAPTIS Study ACTIVE_NOT_RECRUITING NCT07245719 Stryker Universal Midface and Upper-Face Fixation System: A Retrospective Post Market Follow Up COMPLETED NCT07485829 Zimmer Biomet-RibFix Titan RECRUITING

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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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