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FDA 510(k)

KYPHON INFLATION SYRINGE

K-Number: K103231 · 2011-01-24

ApplicantMedtronic Spine, LLC
Decision Date2011-01-24
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KYPHON INFLATION SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Spine, LLC. It received FDA 510(k) clearance on 2011-01-24 under 510(k) number K103231. 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 INFLATION SYRINGE?

KYPHON INFLATION SYRINGE is a medical device that received FDA 510(k) clearance on 2011-01-24. The listed applicant is Medtronic Spine, LLC. The 510(k) number is K103231.

When did KYPHON INFLATION SYRINGE receive FDA 510(k) clearance?

KYPHON INFLATION SYRINGE received FDA 510(k) clearance on 2011-01-24, under 510(k) number K103231.

Who is the listed applicant for KYPHON INFLATION SYRINGE?

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

What is the FDA product code for KYPHON INFLATION SYRINGE?

The FDA product code for KYPHON INFLATION SYRINGE is HRX.

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Other records listing Medtronic Spine, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: HRX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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