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FDA 510(k)

GUARDIAN INFLATABLE BONE EXPANDER SYSTEM

K-Number: K111593 · 2011-11-18

ApplicantBm Korea Co., Ltd.
Decision Date2011-11-18
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GUARDIAN INFLATABLE BONE EXPANDER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bm Korea Co., Ltd.. It received FDA 510(k) clearance on 2011-11-18 under 510(k) number K111593. 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 GUARDIAN INFLATABLE BONE EXPANDER SYSTEM?

GUARDIAN INFLATABLE BONE EXPANDER SYSTEM is a medical device that received FDA 510(k) clearance on 2011-11-18. The listed applicant is Bm Korea Co., Ltd.. The 510(k) number is K111593.

When did GUARDIAN INFLATABLE BONE EXPANDER SYSTEM receive FDA 510(k) clearance?

GUARDIAN INFLATABLE BONE EXPANDER SYSTEM received FDA 510(k) clearance on 2011-11-18, under 510(k) number K111593.

Who is the listed applicant for GUARDIAN INFLATABLE BONE EXPANDER SYSTEM?

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

What is the FDA product code for GUARDIAN INFLATABLE BONE EXPANDER SYSTEM?

The FDA product code for GUARDIAN INFLATABLE BONE EXPANDER SYSTEM is NDN.

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Other records listing Bm Korea Co., Ltd. as applicant

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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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