Neobiotech Co., Ltd.
Wonju-si Gangwon, KR
NEOBIOTECH CO., LTD. appears in FDA device records in Wonju-si Gangwon, KR. FDA records list 17 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 17 510(k) clearances for Neobiotech Co., Ltd. between 2004 and 2024. The busiest year on record is 2012, with 4. The most recent is 2024, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 1 |
| 2009 | 3 |
| 2012 | 4 |
| 2017 | 1 |
| 2018 | 4 |
| 2019 | 1 |
| 2021 | 1 |
| 2024 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K232528 | Protective Cap | NHA | Substantially Equivalent | |
| K232049 | IS-III active Short Implant | DZE | Substantially Equivalent | |
| K210903 | IS Multi Unit Abutment System | NHA | Substantially Equivalent | |
| K190849 | IS-III active System_S-narrow Type | DZE | Substantially Equivalent | |
| K181137 | IT-III active System | DZE | Substantially Equivalent | |
| K181138 | IS-III active System | DZE | Substantially Equivalent | |
| K181178 | S-mini active Fixture | DZE | Substantially Equivalent | |
| K173938 | IS-III HActive Fixture | DZE | Substantially Equivalent | |
| K160991 | Neo GBR System | DZL | Substantially Equivalent | |
| K120503 | CMI IMPLANT IS II ACTIVE | DZE | Substantially Equivalent | |
| K113554 | CMI IMPLANT IS SYSTEM | DZE | Substantially Equivalent | |
| K112540 | S-MINI IMPLANT SYSTEM | DZE | Substantially Equivalent | |
| K111761 | NEO TITANIUM MESH, CTI-MEM | JEY | Substantially Equivalent | |
| K090377 | SINUS QUICK EB SYSTEM | DZE | Substantially Equivalent | |
| K090825 | SQ IS SYSTEM | DZE | Substantially Equivalent | |
| K090527 | SINUS QUICK IT SYSTEM | DZE | Substantially Equivalent | |
| K042339 | NEOPLANT IMPLANT SYSTEM | DZE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004730368 | 3004730368 | NEOBIOTECH CO., LTD. | 70, Sinpyeong-ro, Jijeong-myeon, Wonju-si Gangwon 26351 KR | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain