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FDA 510(k)

GENERATION 4 BONE CEMENT

K-Number: K993836 · 2001-12-19

ApplicantBiomet, Inc.
Decision Date2001-12-19
Product CodeLOD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GENERATION 4 BONE CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2001-12-19 under 510(k) number K993836. 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 GENERATION 4 BONE CEMENT?

GENERATION 4 BONE CEMENT is a medical device that received FDA 510(k) clearance on 2001-12-19. The listed applicant is Biomet, Inc.. The 510(k) number is K993836.

When did GENERATION 4 BONE CEMENT receive FDA 510(k) clearance?

GENERATION 4 BONE CEMENT received FDA 510(k) clearance on 2001-12-19, under 510(k) number K993836.

Who is the listed applicant for GENERATION 4 BONE CEMENT?

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

What is the FDA product code for GENERATION 4 BONE CEMENT?

The FDA product code for GENERATION 4 BONE CEMENT is LOD.

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Other records listing Biomet, Inc. as applicant

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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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