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FDA 510(k)

OSSEOFLEX SB INFLATABLE BONE TAMP

K-Number: K122533 · 2012-10-23

ApplicantOsseon Therapeutics, Inc.
Decision Date2012-10-23
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSSEOFLEX SB INFLATABLE BONE TAMP is the device name listed in this FDA 510(k) record. The listed applicant is Osseon Therapeutics, Inc.. It received FDA 510(k) clearance on 2012-10-23 under 510(k) number K122533. 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 OSSEOFLEX SB INFLATABLE BONE TAMP?

OSSEOFLEX SB INFLATABLE BONE TAMP is a medical device that received FDA 510(k) clearance on 2012-10-23. The listed applicant is Osseon Therapeutics, Inc.. The 510(k) number is K122533.

When did OSSEOFLEX SB INFLATABLE BONE TAMP receive FDA 510(k) clearance?

OSSEOFLEX SB INFLATABLE BONE TAMP received FDA 510(k) clearance on 2012-10-23, under 510(k) number K122533.

Who is the listed applicant for OSSEOFLEX SB INFLATABLE BONE TAMP?

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

What is the FDA product code for OSSEOFLEX SB INFLATABLE BONE TAMP?

The FDA product code for OSSEOFLEX SB INFLATABLE BONE TAMP 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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