FDA 510(k)

SP-LINK System

K-Number: K182352 · 2018-11-21

Decision Date2018-11-21

Product CodePEK

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

SP-LINK System is a medical device manufactured by Medical Designs, LLC. It received FDA 510(k) clearance on 2018-11-21 under approval number K182352. 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 SP-LINK System?

SP-LINK System is a medical device that received FDA 510(k) clearance on 2018-11-21. It is manufactured by Medical Designs, LLC. The 510(k) number is K182352.

When was SP-LINK System approved by the FDA?

SP-LINK System received FDA 510(k) clearance on 2018-11-21, under approval number K182352.

What company makes SP-LINK System?

SP-LINK System is manufactured by Medical Designs, LLC.

What is the FDA product code for SP-LINK System?

The FDA product code for SP-LINK System is PEK.

Other Devices by Medical Designs, LLC

K181591Fixated Asfora BULLET CAGE® (FABC)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.