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FDA 510(k)

Precision Screw

K-Number: K160385 · 2016-07-27

ApplicantCryptych Pty, Ltd.
Decision Date2016-07-27
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Precision Screw is a medical device manufactured by Cryptych Pty, Ltd.. It received FDA 510(k) clearance on 2016-07-27 under approval number K160385. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Precision Screw?

Precision Screw is a medical device that received FDA 510(k) clearance on 2016-07-27. It is manufactured by Cryptych Pty, Ltd.. The 510(k) number is K160385.

When was Precision Screw approved by the FDA?

Precision Screw received FDA 510(k) clearance on 2016-07-27, under approval number K160385.

What company makes Precision Screw?

Precision Screw is manufactured by Cryptych Pty, Ltd..

What is the FDA product code for Precision Screw?

The FDA product code for Precision Screw is OLO.

Other Devices by Cryptych Pty, Ltd.

K200705Nurochek 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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