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

Cheonan Si, Chungnam, KR

CORENTEC CO., LTD. appears in FDA device records in Cheonan Si, Chungnam, KR. FDA records list 33 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
33
PMA records
0
Recall records
3
Registered establishments
1

510(k) clearance history

FDA records hold 33 510(k) clearances for Corentec Co., Ltd. between 2010 and 2025. The busiest year on record is 2012, with 5. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for Corentec Co., Ltd., by decision year
YearClearances
20101
20112
20125
20132
20152
20163
20173
20192
20203
20212
20223
20232
20242
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K250889EXULT Knee Replacement SystemJWHSubstantially Equivalent
K242401EXULT Knee Replacement SystemJWHSubstantially Equivalent
K242046EXULT Knee Replacement SystemJWHSubstantially Equivalent
K223828BENCOX Delta Option HeadsLZOSubstantially Equivalent
K223223BENCOX Mirabo Z Cup CortiniumLPHSubstantially Equivalent
K222278LOSPA TKR System Instrumentation, EXULT TKR System InstrumentationJWHSubstantially Equivalent
K210614BENCOX Mirabo Z Cup CortiniumLPHSubstantially Equivalent
K220468BENCOX Mirabo Cup SystemLPHSubstantially Equivalent
K212034LOSPA TKR SystemJWHSubstantially Equivalent
K211866Bencox THR SystemLPHSubstantially Equivalent
K201851EXULT Femoral component trial - Left, EXULT Femoral component trial - RightJWHSubstantially Equivalent
K200395LOSPA II Knee System (EXULT Knee Replacement System)JWHSubstantially Equivalent
K200267LOSPA® IS™ Spinal Fixation SystemNKBSubstantially Equivalent
K192507LOSPA II Knee SystemJWHSubstantially Equivalent
K182221Bencox Mirabo Cup Multi HoleLPHSubstantially Equivalent
K172806Bencox Mirabo Cup SystemLPHSubstantially Equivalent
K170243LOSPA IS TLIF & DLIF CagesMAXSubstantially Equivalent
K161641LOSPA IS ACP SystemKWQSubstantially Equivalent
K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemLPHSubstantially Equivalent
K160157LOSPA Modular Knee SystemJWHSubstantially Equivalent
K152084Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone PlugLPHSubstantially Equivalent
K151408LOSPA IS Spinal SystemMAXSubstantially Equivalent
K150007Modified Bencox Hip SystemLPHSubstantially Equivalent
K132644LOSPA IS PEDICLE SCREW (MONOAXIAL & POLYAXIAL), LOSPA IS ROD- STRAIGHT (STANDARD), LOSPA IS ROD- PRE BENT (STANDARD & BUMNISubstantially Equivalent
K130673LOSPA TOTAL KNEE REPLACEMENT SYSTEMJWHSubstantially Equivalent
K122099BENCOX II STEM, BENCOX METAL HEADLPHSubstantially Equivalent
K121665BENCOX FORET & BENCOX DELTALZOSubstantially Equivalent
K120924BENCOX MIRABO CUP BENCOX MIRABO INSERT (STANDARD& ELEVATED TYES) BENCOX MIRABO CUP SCREW HOLE PLUGLPHSubstantially Equivalent
K121037LOSPA TIBIAL BASE PLATEJWHSubstantially Equivalent
K110404EAUM TOTAL KNEE SYSTEMJWHSubstantially Equivalent
K112019BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUPKWYSubstantially Equivalent
K103431COREN TOTAL HIP SYSTEMLPHSubstantially Equivalent
K092076AEGIS & AEGIS II SPINAL SYSTEMMNISubstantially Equivalent

Registered establishments

FDA registered establishments for Corentec Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30091060923009106092CORENTEC CO., LTD.12,Yeongsanhong 1-gil, Ipjang-Myeon,, Cheonan Si, Chungnam 31056 KR2026and 45 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1935-2024LOSPA Patella Component Model/Catalog Number: 01.10.9XX Software Version: N/A Product Description: PatellaDue to unsupported 10 year expiration date.Class IIOpen, Classified
Z-1934-2024LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Description: Tibial InsertDue to unsupported 10 year expiration date.Class IIOpen, Classified
Z-1454-2017Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343Lot may contain the wrong instruction (Instruction for Chinese customer) instead of correct US instructions for use.Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain