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FDA 510(k)

SHIELD KYPHOPLASTY SYSTEM

K-Number: K093477 · 2011-12-08

ApplicantSoteira, Inc.
Decision Date2011-12-08
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SHIELD KYPHOPLASTY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Soteira, Inc.. It received FDA 510(k) clearance on 2011-12-08 under 510(k) number K093477. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHIELD KYPHOPLASTY SYSTEM?

SHIELD KYPHOPLASTY SYSTEM is a medical device that received FDA 510(k) clearance on 2011-12-08. The listed applicant is Soteira, Inc.. The 510(k) number is K093477.

When did SHIELD KYPHOPLASTY SYSTEM receive FDA 510(k) clearance?

SHIELD KYPHOPLASTY SYSTEM received FDA 510(k) clearance on 2011-12-08, under 510(k) number K093477.

Who is the listed applicant for SHIELD KYPHOPLASTY SYSTEM?

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

What is the FDA product code for SHIELD KYPHOPLASTY SYSTEM?

The FDA product code for SHIELD KYPHOPLASTY SYSTEM is NDN.

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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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