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FDA 510(k)

SPECTRUM® GV Bone Cement

K-Number: K231556 · 2023-12-20

ApplicantOsteoremedies, LLC
Decision Date2023-12-20
Product CodeLOD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPECTRUM® GV Bone Cement is the device name listed in this FDA 510(k) record. The listed applicant is Osteoremedies, LLC. It received FDA 510(k) clearance on 2023-12-20 under 510(k) number K231556. 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 SPECTRUM® GV Bone Cement?

SPECTRUM® GV Bone Cement is a medical device that received FDA 510(k) clearance on 2023-12-20. The listed applicant is Osteoremedies, LLC. The 510(k) number is K231556.

When did SPECTRUM® GV Bone Cement receive FDA 510(k) clearance?

SPECTRUM® GV Bone Cement received FDA 510(k) clearance on 2023-12-20, under 510(k) number K231556.

Who is the listed applicant for SPECTRUM® GV Bone Cement?

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

What is the FDA product code for SPECTRUM® GV Bone Cement?

The FDA product code for SPECTRUM® GV Bone Cement is LOD.

Other records listing Osteoremedies, LLC 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.

K262290REMEDY POLY+PLUS SNAP FIT Acetabular CupK253675OsteoRemedies Hip Spacer SystemK250760SPECTRUM GV Bone CementK242377REMEDY Stemmed Knee Spacer System with All-Poly Tibial ComponentK223650REMEDY Stemmed Knee SpacerK192995OsteoRemedies Hip Spacer System

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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 GmbHK211163Bone Cement Genta, Bone Cement HV, Bone Cement LVTecres S.P.A.K212729Bone Cement-Normal ViscosityBiomecanica Industria E Comerciode Produtos Ortopedicos LtdaK211869OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cementOrmed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE

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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