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FDA 510(k)

Deformity Analysis and Correction Software (DACS) and Instrumentation

K-Number: K180539 · 2018-08-13

ApplicantArrowhead Medical Device Technologies, LLC
Decision Date2018-08-13
Product CodeOSN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Deformity Analysis and Correction Software (DACS) and Instrumentation is the device name listed in this FDA 510(k) record. The listed applicant is Arrowhead Medical Device Technologies, LLC. It received FDA 510(k) clearance on 2018-08-13 under 510(k) number K180539. The device is classified under product code OSN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Deformity Analysis and Correction Software (DACS) and Instrumentation?

Deformity Analysis and Correction Software (DACS) and Instrumentation is a medical device that received FDA 510(k) clearance on 2018-08-13. The listed applicant is Arrowhead Medical Device Technologies, LLC. The 510(k) number is K180539.

When did Deformity Analysis and Correction Software (DACS) and Instrumentation receive FDA 510(k) clearance?

Deformity Analysis and Correction Software (DACS) and Instrumentation received FDA 510(k) clearance on 2018-08-13, under 510(k) number K180539.

Who is the listed applicant for Deformity Analysis and Correction Software (DACS) and Instrumentation?

The FDA 510(k) record lists Arrowhead Medical Device Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Deformity Analysis and Correction Software (DACS) and Instrumentation?

The FDA product code for Deformity Analysis and Correction Software (DACS) and Instrumentation is OSN.

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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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