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FDA 510(k)

SCS 17-01

K-Number: K190956 · 2020-01-30

ApplicantAnika Therapeutics, Inc.
Decision Date2020-01-30
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SCS 17-01 is a medical device manufactured by Anika Therapeutics, Inc.. It received FDA 510(k) clearance on 2020-01-30 under approval number K190956. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCS 17-01?

SCS 17-01 is a medical device that received FDA 510(k) clearance on 2020-01-30. It is manufactured by Anika Therapeutics, Inc.. The 510(k) number is K190956.

When was SCS 17-01 approved by the FDA?

SCS 17-01 received FDA 510(k) clearance on 2020-01-30, under approval number K190956.

What company makes SCS 17-01?

SCS 17-01 is manufactured by Anika Therapeutics, Inc..

What is the FDA product code for SCS 17-01?

The FDA product code for SCS 17-01 is MQV.

Other Devices by Anika Therapeutics, Inc.

K173008SCS 17-01 K212083Tactoset Injectable Bone Substitute K231968Tactoset® Injectable Bone Substitute K223538Integrity Implant K223860Integrity™ Bone Staple Fixation System K222487Anika Tissue Tack Fixation System

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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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