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FDA 510(k)

COBALT V RADIOPAQUE VERTEBROPLASTY BONE CEMENT

K-Number: K070015 · 2007-11-30

ApplicantBiomet Manufacturing Corp
Decision Date2007-11-30
Product CodeLOD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COBALT V RADIOPAQUE VERTEBROPLASTY BONE CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Manufacturing Corp. It received FDA 510(k) clearance on 2007-11-30 under 510(k) number K070015. The device is classified under product code LOD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBALT V RADIOPAQUE VERTEBROPLASTY BONE CEMENT?

COBALT V RADIOPAQUE VERTEBROPLASTY BONE CEMENT is a medical device that received FDA 510(k) clearance on 2007-11-30. The listed applicant is Biomet Manufacturing Corp. The 510(k) number is K070015.

When did COBALT V RADIOPAQUE VERTEBROPLASTY BONE CEMENT receive FDA 510(k) clearance?

COBALT V RADIOPAQUE VERTEBROPLASTY BONE CEMENT received FDA 510(k) clearance on 2007-11-30, under 510(k) number K070015.

Who is the listed applicant for COBALT V RADIOPAQUE VERTEBROPLASTY BONE CEMENT?

The FDA 510(k) record lists Biomet Manufacturing Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COBALT V RADIOPAQUE VERTEBROPLASTY BONE CEMENT?

The FDA product code for COBALT V RADIOPAQUE VERTEBROPLASTY BONE CEMENT is LOD.

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Related Devices (Code: LOD)

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.

K254107Refobacin Bone Cement R (110034355)Biomet FranceK250760SPECTRUM GV Bone CementOsteoremedies, LLCK241674OSTEOPAL® VHeraeus Medical GmbHK231556SPECTRUM® GV Bone CementOsteoremedies, LLCK211163Bone Cement Genta, Bone Cement HV, Bone Cement LVTecres S.P.A.K212729Bone Cement-Normal ViscosityBiomecanica Industria E Comerciode Produtos Ortopedicos Ltda

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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