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FDA 510(k)

coflex-IF

K-Number: K153302 · 2016-09-08

ApplicantParadigm Spine, LLC
Decision Date2016-09-08
Product CodePEK
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

coflex-IF is a medical device manufactured by Paradigm Spine, LLC. It received FDA 510(k) clearance on 2016-09-08 under approval number K153302. 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 coflex-IF?

coflex-IF is a medical device that received FDA 510(k) clearance on 2016-09-08. It is manufactured by Paradigm Spine, LLC. The 510(k) number is K153302.

When was coflex-IF approved by the FDA?

coflex-IF received FDA 510(k) clearance on 2016-09-08, under approval number K153302.

What company makes coflex-IF?

coflex-IF is manufactured by Paradigm Spine, LLC.

What is the FDA product code for coflex-IF?

The FDA product code for coflex-IF is PEK.

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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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