FDA 510(k)

Dunamis Force DFX Tensile Tape

K-Number: K153746 · 2016-03-03

Decision Date2016-03-03

Product CodeGAT

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Dunamis Force DFX Tensile Tape is a medical device manufactured by Dunamis, LLC. It received FDA 510(k) clearance on 2016-03-03 under approval number K153746. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dunamis Force DFX Tensile Tape?

Dunamis Force DFX Tensile Tape is a medical device that received FDA 510(k) clearance on 2016-03-03. It is manufactured by Dunamis, LLC. The 510(k) number is K153746.

When was Dunamis Force DFX Tensile Tape approved by the FDA?

Dunamis Force DFX Tensile Tape received FDA 510(k) clearance on 2016-03-03, under approval number K153746.

What company makes Dunamis Force DFX Tensile Tape?

Dunamis Force DFX Tensile Tape is manufactured by Dunamis, LLC.

What is the FDA product code for Dunamis Force DFX Tensile Tape?

The FDA product code for Dunamis Force DFX Tensile Tape is GAT.

Other Devices by Dunamis, LLC

K160996Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm K191319Dunamis Fixation Button System K193245Dunamis PunchTac Suture Anchors

Related Devices (Code: GAT)

K160854MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation SutureBiomet Manafacturing Corp. K162247PERMATAPEMedos International SARL K162310XBraid TT Suture TapeStryker K161638SPEEDTRAP Graft Preparation SystemMedos International SARL K153089'cottony' II TAPE, PLEDGETSTeleflexmedical, Inc. K153087IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse CurvedIvy Sports Medicine, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.