510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Innobiosurg Co., Ltd.

Daejeon, KR

INNOBIOSURG CO., LTD. appears in FDA device records in Daejeon, KR. FDA records list 15 510(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) clearances
15
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 15 510(k) clearances for Innobiosurg Co., Ltd. between 2015 and 2022. The busiest year on record is 2020, with 6. The most recent is 2022, with 2.

Clearances by year, as a table
510(k) clearance decisions for Innobiosurg Co., Ltd., by decision year
YearClearances
20151
20162
20171
20181
20206
20212
20222
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K220517IBS SystemDZESubstantially Equivalent
K220079Magicore Narrow SystemDZESubstantially Equivalent
K212517Magicore SystemDZESubstantially Equivalent
K203344Premilled Titanium Block SystemNHASubstantially Equivalent
K202418Magic UCLA Abutment SystemNHASubstantially Equivalent
K202479IBS Implant SystemDZESubstantially Equivalent
K201981Magicore SystemDZESubstantially Equivalent
K201621Magicore II SystemNHASubstantially Equivalent
K200753IBS Implant System IINHASubstantially Equivalent
K192197Magicore II SystemDZESubstantially Equivalent
K173120CCM Abutment SystemNHASubstantially Equivalent
K162099IBS Implant System IIDZESubstantially Equivalent
K153350IBS Implant SystemDZESubstantially Equivalent
K152520Magicore SystemDZESubstantially Equivalent
K140806IBS IMPLANT SYSTEMDZESubstantially Equivalent

Registered establishments

FDA registered establishments for Innobiosurg Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30083096543008309654INNOBIOSURG CO., LTD.44-19, Techno Street 10, YUSUNG-GU,, Daejeon 305-500 KR2026

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