Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Refobacin Bone Cement R

K-Number: K171540 · 2017-08-30

ApplicantBiomet, Inc.
Decision Date2017-08-30
Product CodeLOD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Refobacin Bone Cement R is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2017-08-30 under 510(k) number K171540. 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 Refobacin Bone Cement R?

Refobacin Bone Cement R is a medical device that received FDA 510(k) clearance on 2017-08-30. The listed applicant is Biomet, Inc.. The 510(k) number is K171540.

When did Refobacin Bone Cement R receive FDA 510(k) clearance?

Refobacin Bone Cement R received FDA 510(k) clearance on 2017-08-30, under 510(k) number K171540.

Who is the listed applicant for Refobacin Bone Cement R?

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 Refobacin Bone Cement R?

The FDA product code for Refobacin Bone Cement R is LOD.

Other records listing Biomet, 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.

K253434OSSTM Orthopedic Salvage SystemK251270Taperloc® Complete Hip StemK241014Biomet Kirschner Wires (K-Wires)K222760StageOne™ Select Hip Cement Spacer MoldsK221968StageOne™ Shoulder Cement Spacer MoldsK213287StageOne Knee Cement Spacer Molds

View all 36 devices →

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.

↑