Superbax Standards and Sizes
Superbax is manufactured under the following standards:
- ISO 9001:2000(International Quality Management System)
- ISO 13485(International Quality System Medical Devices)
- EN 46002(European Quality System Medical Devices)
- CE Mark
- FDA ER No.9611754 and Device Listing No. B 115761 in USA
- Notification No.BE/CA01/2-03702-000011 Belgium
- Notification No.BE/CA01/2-03702-00002 Belgium
- Clinical consultation:Department fo Orthopedic Surgery, Inje University, Seoul Paik Hospital, Korea
- Korean Patent No.:142202
- Japanese Patenet No.:2911437
- US Patent No.:5980560
- International application No.:PCT/KR00/00368

