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FDA 510(k)

CoFix System

K-Number: K201704 · 2020-08-04

ApplicantParadigm Spine GmbH
Decision Date2020-08-04
Product CodePEK
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CoFix System is a medical device manufactured by Paradigm Spine GmbH. It received FDA 510(k) clearance on 2020-08-04 under approval number K201704. The device is classified under product code PEK. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CoFix System?

CoFix System is a medical device that received FDA 510(k) clearance on 2020-08-04. It is manufactured by Paradigm Spine GmbH. The 510(k) number is K201704.

When was CoFix System approved by the FDA?

CoFix System received FDA 510(k) clearance on 2020-08-04, under approval number K201704.

What company makes CoFix System?

CoFix System is manufactured by Paradigm Spine GmbH.

What is the FDA product code for CoFix System?

The FDA product code for CoFix System is PEK.

Other Devices by Paradigm Spine GmbH

K201453Fortilink Cages with TiPlus Technology

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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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