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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Cement
510(k) Number K211869
Device Name OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement
Applicant
Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE
Ticaret Limited S
Macun Mahallesi 177 Cadde No:19 H/7 Timko Is Yerleri
Ankara,  TR 06200
Applicant Contact Kenan Kara
Correspondent
Medcer Uluslararasi Medikal Belgelendirme Anonim Sirketi
Taspinar Mahallesi 2800. Caddesi A-2 Apt. No:6 B/49
Ankara,  TR 06830
Correspondent Contact Mehmet Fatih Ormeci
Regulation Number888.3027
Classification Product Code
LOD  
Subsequent Product Code
MBB  
Date Received06/16/2021
Decision Date 05/19/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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