Philippines FDA registration MDR-07341

Osstem Implant Ortho Kit

Philippines·Osstem Implant Co., Ltd. - 3, Magukjungang 12-ro, Gangseo-gu, Seoul, 07789, Republic of Korea Mfd. by: Osstem Implant Co., Ltd. - 66-16, Bansong-ro 513beon-gil, Haeundae-gu Busan, Korea·Korea·Issued May 08, 2025 – October 26, 2029

Device information

Product Name: Osstem Implant Ortho Kit
Registration Number: MDR-07341

Manufacturer details

Manufacturer: Osstem Implant Co., Ltd. - 3, Magukjungang 12-ro, Gangseo-gu, Seoul, 07789, Republic of Korea Mfd. by: Osstem Implant Co., Ltd. - 66-16, Bansong-ro 513beon-gil, Haeundae-gu Busan, Korea
Country of Origin: Korea

Importer & distribution

Importer/Distributor: Osstem Philippines, Inc.

Registration dates

Issuance Date: May 08, 2025
Expiry Date: October 26, 2029

About this record

Access comprehensive regulatory information for Osstem Implant Ortho Kit in the Philippines medical device market through Pure Global AI's free database. This device is registered under FDA registration number MDR-07341 and manufactured by Osstem Implant Co., Ltd. - 3, Magukjungang 12-ro, Gangseo-gu, Seoul, 07789, Republic of Korea Mfd. by: Osstem Implant Co., Ltd. - 66-16, Bansong-ro 513beon-gil, Haeundae-gu Busan, Korea in Korea. The device was registered on May 08, 2025.

This page provides complete registration details including manufacturer information, importer/distributor details (Osstem Philippines, Inc.), and regulatory compliance data from the official Philippines FDA medical device database. Pure Global AI offers free access to Philippines' complete medical device registry, helping global MedTech companies navigate FDA regulations efficiently.