FDA 510(k)

Precision Screw

K-Number: K160385 · 2016-07-27

Decision Date2016-07-27

Product CodeOLO

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Precision Screw is the device name listed in this FDA 510(k) record. The listed applicant is Cryptych Pty, Ltd.. It received FDA 510(k) clearance on 2016-07-27 under 510(k) 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. The listed applicant is Cryptych Pty, Ltd.. The 510(k) number is K160385.

When did Precision Screw receive FDA 510(k) clearance?

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

Who is the listed applicant for Precision Screw?

The FDA 510(k) record lists Cryptych Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Precision Screw?

The FDA product code for Precision Screw is OLO.

Other records listing Cryptych Pty, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.