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FDA 510(k)

SPECTRUM GV Bone Cement

K-Number: K250760 · 2025-04-02

ApplicantOsteoremedies, LLC
Decision Date2025-04-02
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 2025-04-02 under 510(k) number K250760. 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 2025-04-02. The listed applicant is Osteoremedies, LLC. The 510(k) number is K250760.

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

SPECTRUM GV Bone Cement received FDA 510(k) clearance on 2025-04-02, under 510(k) number K250760.

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 SystemK242377REMEDY Stemmed Knee Spacer System with All-Poly Tibial ComponentK231556SPECTRUM® GV Bone CementK223650REMEDY 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 FranceK241674OSTEOPAL® 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 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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