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FDA 510(k)

ORTHOSIZE

K-Number: K120115 · 2012-03-14

ApplicantOrthosize, LLC
Decision Date2012-03-14
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ORTHOSIZE is the device name listed in this FDA 510(k) record. The listed applicant is Orthosize, LLC. It received FDA 510(k) clearance on 2012-03-14 under 510(k) number K120115. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHOSIZE?

ORTHOSIZE is a medical device that received FDA 510(k) clearance on 2012-03-14. The listed applicant is Orthosize, LLC. The 510(k) number is K120115.

When did ORTHOSIZE receive FDA 510(k) clearance?

ORTHOSIZE received FDA 510(k) clearance on 2012-03-14, under 510(k) number K120115.

Who is the listed applicant for ORTHOSIZE?

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

What is the FDA product code for ORTHOSIZE?

The FDA product code for ORTHOSIZE is LLZ.

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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.

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