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FDA 510(k)

SPEEDTRAP Graft Preparation System

K-Number: K161638 · 2016-11-07

ApplicantMedos International SARL
Decision Date2016-11-07
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SPEEDTRAP Graft Preparation System is a medical device manufactured by Medos International SARL. It received FDA 510(k) clearance on 2016-11-07 under approval number K161638. 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 SPEEDTRAP Graft Preparation System?

SPEEDTRAP Graft Preparation System is a medical device that received FDA 510(k) clearance on 2016-11-07. It is manufactured by Medos International SARL. The 510(k) number is K161638.

When was SPEEDTRAP Graft Preparation System approved by the FDA?

SPEEDTRAP Graft Preparation System received FDA 510(k) clearance on 2016-11-07, under approval number K161638.

What company makes SPEEDTRAP Graft Preparation System?

SPEEDTRAP Graft Preparation System is manufactured by Medos International SARL.

What is the FDA product code for SPEEDTRAP Graft Preparation System?

The FDA product code for SPEEDTRAP Graft Preparation System is GAT.

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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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