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FDA 510(k)

e-fix E35/E36

K-Number: K161241 · 2016-10-05

ApplicantAlber GmbH
Decision Date2016-10-05
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

e-fix E35/E36 is a medical device manufactured by Alber GmbH. It received FDA 510(k) clearance on 2016-10-05 under approval number K161241. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the e-fix E35/E36?

e-fix E35/E36 is a medical device that received FDA 510(k) clearance on 2016-10-05. It is manufactured by Alber GmbH. The 510(k) number is K161241.

When was e-fix E35/E36 approved by the FDA?

e-fix E35/E36 received FDA 510(k) clearance on 2016-10-05, under approval number K161241.

What company makes e-fix E35/E36?

e-fix E35/E36 is manufactured by Alber GmbH.

What is the FDA product code for e-fix E35/E36?

The FDA product code for e-fix E35/E36 is ITI.

Other Devices by Alber GmbH

K151717twion K192618e-Motion M25 K192016SMOOV O10 K221215e-motion M25

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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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