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FDA 510(k)

THE VAULT SYSTEM

K-Number: K124051 · 2013-05-17

ApplicantSomersault Orthopedics, Inc.
Decision Date2013-05-17
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

THE VAULT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Somersault Orthopedics, Inc.. It received FDA 510(k) clearance on 2013-05-17 under 510(k) number K124051. 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 THE VAULT SYSTEM?

THE VAULT SYSTEM is a medical device that received FDA 510(k) clearance on 2013-05-17. The listed applicant is Somersault Orthopedics, Inc.. The 510(k) number is K124051.

When did THE VAULT SYSTEM receive FDA 510(k) clearance?

THE VAULT SYSTEM received FDA 510(k) clearance on 2013-05-17, under 510(k) number K124051.

Who is the listed applicant for THE VAULT SYSTEM?

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

What is the FDA product code for THE VAULT SYSTEM?

The FDA product code for THE VAULT SYSTEM 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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