Kyungwon Medical Co., Ltd. · 89-08 · KOREA (THE REPUBLIC OF)
For Kyungwon Medical Co., Ltd. · 89-08 · KOREA (THE REPUBLIC OF), import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is KOREA (THE REPUBLIC OF); product is PolyBone Original (Bone Graft Substitute) | PolyBone Original (Bone Graft Substitute); product code is 87 M - - BP Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) | 87 M - - QV Filler, Calcium Sulfate Preformed Pellets; date published is 01/27/2016; address is 765, Jeongjungyeonje-ro , Osong-eup, Chungcheongbuk-do KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.
- Firm
- Kyungwon Medical Co., Ltd. verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- KOREA (THE REPUBLIC OF) verified
- Address
- 765, Jeongjungyeonje-ro , Osong-eup, Chungcheongbuk-do KOREA (THE REPUBLIC OF) verified
- Date published
- 01/27/2016 verified
- Product code
- 87 M - - BP Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) | 87 M - - QV Filler, Calcium Sulfate Preformed Pellets each item verified
- Product
- PolyBone Original (Bone Graft Substitute) | PolyBone Original (Bone Graft Substitute) each item verified
What the source says
Kyungwon Medical Co., Ltd. Date Published : 01/27/2016 765, Jeongjungyeonje-ro , Osong-eup, Chungcheongbuk-do KOREA (THE REPUBLIC OF) 87 M - - BP Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) Date Published: 11/08/2018 Desc: PolyBone Original (Bone Graft Substitute) 87 M - - QV Filler, Calcium Sulfate Preformed Pellets Date Published: 01/27/2016 Desc: PolyBone Original (Bone Graft Substitute)
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.