Cleared Traditional

OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement

K211869 · Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE · Orthopedic
May 2022
Decision
337d
Days
Class 2
Risk

About This 510(k) Submission

K211869 is an FDA 510(k) clearance for the OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement, a Bone Cement (Class II — Special Controls, product code LOD), submitted by Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE (Ankara, TR). The FDA issued a Cleared decision on May 19, 2022, 337 days after receiving the submission on June 16, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number K211869 FDA.gov
FDA Decision Cleared SESE
Date Received June 16, 2021
Decision Date May 19, 2022
Days to Decision 337 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code LOD — Bone Cement
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3027