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FDA 510(k)

KYPHX HV-R, MODEL C01A

K-Number: K033801 · 2004-04-01

ApplicantKyphon, Inc.
Decision Date2004-04-01
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KYPHX HV-R, MODEL C01A is the device name listed in this FDA 510(k) record. The listed applicant is Kyphon, Inc.. It received FDA 510(k) clearance on 2004-04-01 under 510(k) number K033801. 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 KYPHX HV-R, MODEL C01A?

KYPHX HV-R, MODEL C01A is a medical device that received FDA 510(k) clearance on 2004-04-01. The listed applicant is Kyphon, Inc.. The 510(k) number is K033801.

When did KYPHX HV-R, MODEL C01A receive FDA 510(k) clearance?

KYPHX HV-R, MODEL C01A received FDA 510(k) clearance on 2004-04-01, under 510(k) number K033801.

Who is the listed applicant for KYPHX HV-R, MODEL C01A?

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

What is the FDA product code for KYPHX HV-R, MODEL C01A?

The FDA product code for KYPHX HV-R, MODEL C01A is NDN.

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Other records listing Kyphon, Inc. 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.

K073516DISCYPHOR DIRECT CATHETER SYSTEM, DISCYPHOR DIRECT NEEDLES, LONG, DISCYPHOR DIRECT NEEDLES, REGULARK063071DISCYPHOR CATHETER SYSTEM, MODEL D01A; DISCYPHOR INTRODUCER NEEDLE, MODEL D01BK061210FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) CATHETER SYSTEM, MODEL D01A ; INTRODUCER NEEDLE, MODEL D01BK041454KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13AK041584KYPHX HV-R BONE CEMENT, MODEL C01AK032212KYPHX DIRECTIONAL INFLATABLE BONE TAMP, MODELS K16A AND K17A

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Related Devices (Code: 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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