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FDA 510(k)

MicroLink All-Suture Button Fixation System (Radiopaque)

K-Number: K190582 · 2019-06-28

ApplicantConmed Corporation
Decision Date2019-06-28
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MicroLink All-Suture Button Fixation System (Radiopaque) is a medical device manufactured by Conmed Corporation. It received FDA 510(k) clearance on 2019-06-28 under approval number K190582. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MicroLink All-Suture Button Fixation System (Radiopaque)?

MicroLink All-Suture Button Fixation System (Radiopaque) is a medical device that received FDA 510(k) clearance on 2019-06-28. It is manufactured by Conmed Corporation. The 510(k) number is K190582.

When was MicroLink All-Suture Button Fixation System (Radiopaque) approved by the FDA?

MicroLink All-Suture Button Fixation System (Radiopaque) received FDA 510(k) clearance on 2019-06-28, under approval number K190582.

What company makes MicroLink All-Suture Button Fixation System (Radiopaque)?

MicroLink All-Suture Button Fixation System (Radiopaque) is manufactured by Conmed Corporation.

What is the FDA product code for MicroLink All-Suture Button Fixation System (Radiopaque)?

The FDA product code for MicroLink All-Suture Button Fixation System (Radiopaque) is HTN.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07276815 OverStitch NXT Endoscopic Suture System NOT_YET_RECRUITING NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT07489820 Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation NOT_YET_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

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Related Devices (Code: HTN)

K153211M-Fix Acromioclavicular DeviceCoracoid Solutions, Inc. K173550Akros FibuLink™ Syndesmosis Repair KitAkros Medical K172620SyndesMetrics Syndesmosis Repair SystemMortise Medical, LLC K170249GRAVITY™ Syndesmosis LPWrightmedicaltechnologyinc K162996INVISIKNOT Ankle Syndesmosis Repair KitSmith & Nephew, Inc. K170440KISSloc Suture SystemArthrosurface, 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.

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