# Kyungwon Medical Co., Ltd. · 89-08 · KOREA (THE REPUBLIC OF) — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** 765, Jeongjungyeonje-ro , Osong-eup, Chungcheongbuk-do KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 01/27/2016 _(verified: appears in the quote below)_
- **Product code:** 87 M - - BP Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) | 87 M - - QV Filler, Calcium Sulfate Preformed Pellets _(verified: each item appears in the quote below)_
- **Product:** PolyBone Original (Bone Graft Substitute) | PolyBone Original (Bone Graft Substitute) _(verified: each item appears in the quote below)_

## 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)

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).