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FDA 510(k)

INFLATABLE BONE TAMP

K-Number: K090211 · 2009-07-01

ApplicantCardinal Health, Inc.
Decision Date2009-07-01
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INFLATABLE BONE TAMP is the device name listed in this FDA 510(k) record. The listed applicant is Cardinal Health, Inc.. It received FDA 510(k) clearance on 2009-07-01 under 510(k) number K090211. 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 INFLATABLE BONE TAMP?

INFLATABLE BONE TAMP is a medical device that received FDA 510(k) clearance on 2009-07-01. The listed applicant is Cardinal Health, Inc.. The 510(k) number is K090211.

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

INFLATABLE BONE TAMP received FDA 510(k) clearance on 2009-07-01, under 510(k) number K090211.

Who is the listed applicant for INFLATABLE BONE TAMP?

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

What is the FDA product code for INFLATABLE BONE TAMP?

The FDA product code for INFLATABLE BONE TAMP is NDN.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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