OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement— 510(k) K211869

Name: FDA 510(k) clearance K211869
Creator: U.S. Food and Drug Administration
Published: 2022-05-19

Substantially Equivalent

Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE

FDA 510(k) clearance K211869 for OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement, Substantially Equivalent on 2022-05-19. Applicant: Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE. Device class: 2.

Clearance details

Applicant: Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE
Product code: Code LOD
Device class: Class 2
Regulation: 21 CFR 888.3027
Advisory panel: Orthopedic
Date received: 2021-06-16
Decision date: 2022-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ankara, TR

Download summary PDF View on FDA.gov ↗

Recent devices under product code LOD

view all

K254107 — Refobacin Bone Cement R (110034355)2026-04-15
K250760 — SPECTRUM GV Bone Cement2025-04-02
K241674 — OSTEOPAL® V2024-12-05
K231556 — SPECTRUM® GV Bone Cement2023-12-20
K211163 — Bone Cement Genta, Bone Cement HV, Bone Cement LV2023-01-09

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.