Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Dunamis Fixation Button System

K-Number: K191319 · 2019-08-29

ApplicantDunamis, LLC
Decision Date2019-08-29
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Dunamis Fixation Button System is a medical device manufactured by Dunamis, LLC. It received FDA 510(k) clearance on 2019-08-29 under approval number K191319. 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 Dunamis Fixation Button System?

Dunamis Fixation Button System is a medical device that received FDA 510(k) clearance on 2019-08-29. It is manufactured by Dunamis, LLC. The 510(k) number is K191319.

When was Dunamis Fixation Button System approved by the FDA?

Dunamis Fixation Button System received FDA 510(k) clearance on 2019-08-29, under approval number K191319.

What company makes Dunamis Fixation Button System?

Dunamis Fixation Button System is manufactured by Dunamis, LLC.

What is the FDA product code for Dunamis Fixation Button System?

The FDA product code for Dunamis Fixation Button System is MBI.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes 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 NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07245719 Stryker Universal Midface and Upper-Face Fixation System: A Retrospective Post Market Follow Up COMPLETED NCT07485829 Zimmer Biomet-RibFix Titan RECRUITING

Other Devices by Dunamis, LLC

K160996Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm K153746Dunamis Force DFX Tensile Tape K193245Dunamis PunchTac Suture Anchors

Related Devices (Code: MBI)

K163034SUTUREFIX Curved Suture AnchorSmith and Nephew, Inc. K162198GFS UltimateParcus Medical, LLC K162386KATOR Suture AnchorKator, LLC K161033AFX™ Femoral Implant With InserterCayenne Medical, Inc. K160996Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mmDunamis, LLC K161001MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL

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.

↑