Kyungwon Medical Co., Ltd. · 89-08 · KOREA (THE REPUBLIC OF)

For Kyungwon Medical Co., Ltd., import alert is 89-08; country is KOREA (THE REPUBLIC OF); 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)"; 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 2026-09-30.

What the source says

Kyungwon Medical Co., Ltd. Date Published : 01/27/2016 765, Jeongjungyeonje-ro , Osong-eup, Chungcheongbuk-do KOREA (THE REPUBLIC OF)

— accessdata.fda.gov, retrieved 2026-09-15

Where each value comes from

The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.

— all from accessdata.fda.gov, retrieved 2026-09-15

Source

• accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified against source: 2026-09-30. Due for re-check by 2026-11-29. This page as Markdown · OKF bundle · full dataset as JSON.