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

For Neobiotech 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 "RegenOss" Freeze Dried Bone Allograft; product code is 76 L - - YC Bone Grafting Material, Synthetic; date published is 08/09/2018; address is #1001, 36, DIGITAL-RO 27 GIL , 103, e-space, 212-26, Guro-dong , Guro-gu, Seoul Teugbyeolsi KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

- **Firm:** Neobiotech 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:** #1001, 36, DIGITAL-RO 27 GIL , 103, e-space, 212-26, Guro-dong , Guro-gu, Seoul Teugbyeolsi KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 08/09/2018 _(verified: appears in the quote below)_
- **Product code:** 76 L - - YC Bone Grafting Material, Synthetic _(verified: appears in the quote below)_
- **Product:** "RegenOss" Freeze Dried Bone Allograft _(verified: appears in the quote below)_
- **FDA notes:** Class III; 9/25/2009 _(verified: appears in the quote below)_

## What the source says

> Neobiotech Co., Ltd. Date Published : 08/09/2018 #1001, 36, DIGITAL-RO 27 GIL , 103, e-space, 212-26, Guro-dong , Guro-gu, Seoul Teugbyeolsi KOREA (THE REPUBLIC OF) 76 L - - YC Bone Grafting Material, Synthetic Date Published: 08/09/2018 Desc: "RegenOss" Freeze Dried Bone Allograft Notes: Class III; 9/25/2009

## 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/).