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FDA 510(k)

Inspan ScrewLES Fusion System

K-Number: K213266 · 2021-12-03

ApplicantLespine Innovations, LLC
Decision Date2021-12-03
Product CodePEK
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Inspan ScrewLES Fusion System is a medical device manufactured by Lespine Innovations, LLC. It received FDA 510(k) clearance on 2021-12-03 under approval number K213266. 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 Inspan ScrewLES Fusion System?

Inspan ScrewLES Fusion System is a medical device that received FDA 510(k) clearance on 2021-12-03. It is manufactured by Lespine Innovations, LLC. The 510(k) number is K213266.

When was Inspan ScrewLES Fusion System approved by the FDA?

Inspan ScrewLES Fusion System received FDA 510(k) clearance on 2021-12-03, under approval number K213266.

What company makes Inspan ScrewLES Fusion System?

Inspan ScrewLES Fusion System is manufactured by Lespine Innovations, LLC.

What is the FDA product code for Inspan ScrewLES Fusion System?

The FDA product code for Inspan ScrewLES Fusion System 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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