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FDA 510(k)

KYPHX HV-R BONE CEMENT, MODEL C01A

K-Number: K041584 · 2004-07-07

ApplicantKyphon, Inc.
Decision Date2004-07-07
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KYPHX HV-R BONE CEMENT, 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 2004-07-07 under 510(k) number K041584. 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 BONE CEMENT, MODEL C01A?

KYPHX HV-R BONE CEMENT, MODEL C01A is a medical device that received FDA 510(k) clearance on 2004-07-07. The listed applicant is Kyphon, Inc.. The 510(k) number is K041584.

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

KYPHX HV-R BONE CEMENT, MODEL C01A received FDA 510(k) clearance on 2004-07-07, under 510(k) number K041584.

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

The FDA product code for KYPHX HV-R BONE CEMENT, 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,K13AK033801KYPHX HV-R, MODEL C01AK032212KYPHX DIRECTIONAL INFLATABLE BONE TAMP, MODELS K16A AND K17A

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Related Devices (Code: NDN)

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.

K251896XeliteMed SuperM-Fix Spinal Bone CementXelite Biomed , Ltd.K250637VCFix Spinal SystemAmber ImplantsK243537XeliteMed VertehighFix High Viscosity Spinal Bone Cement SystemXelite Biomed , Ltd.K241775XeliteMed VertehighFix High Viscosity Spinal Bone CementXelite Biomed , Ltd.K232842Balloon Inflation SystemNingbo Hicren Biotechnology Co., Ltd.K240084V-STRUT® Vertebral ImplantHyprevention

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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