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FDA 510(k)

KYPHON XPANDER II INFLATABLE BONE TAMP

K-Number: K101864 · 2010-10-14

ApplicantMedtronic
Decision Date2010-10-14
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KYPHON XPANDER II INFLATABLE BONE TAMP is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic. It received FDA 510(k) clearance on 2010-10-14 under 510(k) number K101864. 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 XPANDER II INFLATABLE BONE TAMP?

KYPHON XPANDER II INFLATABLE BONE TAMP is a medical device that received FDA 510(k) clearance on 2010-10-14. The listed applicant is Medtronic. The 510(k) number is K101864.

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

KYPHON XPANDER II INFLATABLE BONE TAMP received FDA 510(k) clearance on 2010-10-14, under 510(k) number K101864.

Who is the listed applicant for KYPHON XPANDER II INFLATABLE BONE TAMP?

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 XPANDER II INFLATABLE BONE TAMP?

The FDA product code for KYPHON XPANDER II INFLATABLE BONE TAMP 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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