FDA 510(k)

FAST-FIX FLEX

K-Number: K203393 · 2021-02-01

Decision Date2021-02-01

Product CodeGAT

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

FAST-FIX FLEX is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2021-02-01 under approval number K203393. 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 FAST-FIX FLEX?

FAST-FIX FLEX is a medical device that received FDA 510(k) clearance on 2021-02-01. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K203393.

When was FAST-FIX FLEX approved by the FDA?

FAST-FIX FLEX received FDA 510(k) clearance on 2021-02-01, under approval number K203393.

What company makes FAST-FIX FLEX?

FAST-FIX FLEX is manufactured by Smith & Nephew, Inc..

What is the FDA product code for FAST-FIX FLEX?

The FDA product code for FAST-FIX FLEX 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.