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FDA 510(k)

S.I.N. Instrument Kits

K-Number: K201688 · 2020-10-21

Decision Date2020-10-21
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

S.I.N. Instrument Kits is a medical device manufactured by S.I.N. - Sistema DE Implante Nacional S.A.. It received FDA 510(k) clearance on 2020-10-21 under approval number K201688. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S.I.N. Instrument Kits?

S.I.N. Instrument Kits is a medical device that received FDA 510(k) clearance on 2020-10-21. It is manufactured by S.I.N. - Sistema DE Implante Nacional S.A.. The 510(k) number is K201688.

When was S.I.N. Instrument Kits approved by the FDA?

S.I.N. Instrument Kits received FDA 510(k) clearance on 2020-10-21, under approval number K201688.

What company makes S.I.N. Instrument Kits?

S.I.N. Instrument Kits is manufactured by S.I.N. - Sistema DE Implante Nacional S.A..

What is the FDA product code for S.I.N. Instrument Kits?

The FDA product code for S.I.N. Instrument Kits is KCT.

Other Devices by S.I.N. - Sistema DE Implante Nacional S.A.

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Related Devices (Code: KCT)

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.