SPECTRUM® GV Bone Cement— 510(k) K231556

Name: FDA 510(k) clearance K231556
Creator: U.S. Food and Drug Administration
Published: 2023-12-20

Substantially Equivalent

Osteoremedies, LLC

FDA 510(k) clearance K231556 for SPECTRUM® GV Bone Cement, Substantially Equivalent on 2023-12-20. Applicant: Osteoremedies, LLC. Device class: 2.

Clearance details

Applicant: Osteoremedies, LLC
Product code: Code LOD
Device class: Class 2
Regulation: 21 CFR 888.3027
Advisory panel: Orthopedic
Date received: 2023-05-30
Decision date: 2023-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LOD

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K254107 — Refobacin Bone Cement R (110034355)2026-04-15
K250760 — SPECTRUM GV Bone Cement2025-04-02
K241674 — OSTEOPAL® V2024-12-05
K211163 — Bone Cement Genta, Bone Cement HV, Bone Cement LV2023-01-09
K212729 — Bone Cement-Normal Viscosity2022-05-31

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K242377 — REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component2024-10-02
K223650 — REMEDY Stemmed Knee Spacer2023-01-05
K192995 — OsteoRemedies Hip Spacer System2020-01-10

Adverse events under product code LOD

product code LOD

Death: 44
Injury: 3,004
Malfunction: 895
Other: 4
Total: 3,947

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.