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FDA 510(k)

KYPHON EXPRESS II INFLATABLE BONE TAMPS

K-Number: K123771 · 2012-12-21

ApplicantMedtronic
Decision Date2012-12-21
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KYPHON EXPRESS II INFLATABLE BONE TAMPS is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic. It received FDA 510(k) clearance on 2012-12-21 under 510(k) number K123771. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KYPHON EXPRESS II INFLATABLE BONE TAMPS?

KYPHON EXPRESS II INFLATABLE BONE TAMPS is a medical device that received FDA 510(k) clearance on 2012-12-21. The listed applicant is Medtronic. The 510(k) number is K123771.

When did KYPHON EXPRESS II INFLATABLE BONE TAMPS receive FDA 510(k) clearance?

KYPHON EXPRESS II INFLATABLE BONE TAMPS received FDA 510(k) clearance on 2012-12-21, under 510(k) number K123771.

Who is the listed applicant for KYPHON EXPRESS II INFLATABLE BONE TAMPS?

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

What is the FDA product code for KYPHON EXPRESS II INFLATABLE BONE TAMPS?

The FDA product code for KYPHON EXPRESS II INFLATABLE BONE TAMPS is HRX.

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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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