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FDA 510(k)

MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT

K-Number: K071927 · 2007-11-21

ApplicantDepuy Spine, A Johnson & Johnson Company
Decision Date2007-11-21
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Spine, A Johnson & Johnson Company. It received FDA 510(k) clearance on 2007-11-21 under 510(k) number K071927. 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 MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT?

MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT is a medical device that received FDA 510(k) clearance on 2007-11-21. The listed applicant is Depuy Spine, A Johnson & Johnson Company. The 510(k) number is K071927.

When did MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT receive FDA 510(k) clearance?

MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT received FDA 510(k) clearance on 2007-11-21, under 510(k) number K071927.

Who is the listed applicant for MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT?

The FDA 510(k) record lists Depuy Spine, A Johnson & Johnson Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT?

The FDA product code for MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT is NDN.

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Other records listing Depuy Spine, A Johnson & Johnson Company 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.

K131802EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEMK102249EXPEDIUM SPINE SYSTEMK071495EXPEDIUM 4.5MM SPINE SYSTEM

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

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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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