Data / Medical devices / South Korea / Corentec Co., Ltd.

Corentec Co., Ltd.: FDA-registered device maker in Cheonan Si, Chungnam, South Korea, 33 510(k) clearances

Name: Corentec Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Corentec Co., Ltd. is registered with the FDA (registration 3009106092) in Cheonan Si, Chungnam, South Korea. It lists 55 device types. The FDA files 33 510(k) clearances under its listings, the newest dated April 17, 2025. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3009106092
Address: 12,Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk Gu, Cheonan Si, Chungnam, South Korea, 31056
Owner or operator: Corentec Co., Ltd. (10037247)
Roles: Exporter to the US, Manufacturer
First device listed: June 28, 2011
Registered through: 2026
Brand names listed: BENCOX, BENCOX Delta Option Head System, BENCOX MIRABO, BENCOX Mirabo Cup, BENCOX Mirabo PE Liner, BENCOX Mirabo Z Cup Cortinium, BENCOX THR SYSTEM, BENCOX THR SYSTEM Instruments and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Arthroscopic	NBH	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Accessories, Fixation, Spinal Intervertebral Body	LYQ	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral Body	KWQ	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Awl	HWJ	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Bender	HXW	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Bit, Drill	HTW	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Broach	HTQ	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Caliper	KTZ	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Chisel, Surgical, Manual	FZO	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Corkscrew	HWI	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Crimper, Pin	HXQ	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Driver, Prosthesis	HWR	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Extractor	HWB	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Forceps	HTD	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Gauge, Depth	HTJ	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Guide, Surgical, Instrument	FZX	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	OQG	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Holder, Needle; Orthopedic	HXK	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Impactor	HWA	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Instrument, Bending Or Contouring	HXP	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Instrument, Compression	HWN	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Instrument, Cutting, Orthopedic	HTZ	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	HWE	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment	KIJ	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment	HSZ	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Cervical	ODP	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Lumbar	MAX	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Knee Arthroplasty Implantation System	OOG	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Orthosis, Spinal Pedicle Fixation	MNI	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Orthosis, Spondylolisthesis Spinal Fixation	MNH	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Osteotome	HWM	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Positioner, Socket	KIL	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Probe	HXB	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	KWY	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	LZO	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	JDI	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	LPH	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	MBH	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	JWH	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Protractor	HTH	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Pusher, Socket	HXO	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Rasp	HTR	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Reamer	HTO	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Rongeur	HTX	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Screwdriver	HXX	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Spatula, Orthopedic	HXR	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Stripper, Surgical	HRT	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Tamp	HXG	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Tap, Bone	HWX	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Tape, Measuring, Rulers And Calipers	FTY	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Template	HWT	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Thoracolumbosacral Pedicle Screw System	NKB	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Wrench	HXC	1	Exporter to the US, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 17, 2025	K250889	EXULT Knee Replacement System	JWH	Substantially Equivalent	Corentec Co., Ltd.	accessdata.fda.gov
September 12, 2024	K242401	EXULT Knee Replacement System	JWH	Substantially Equivalent	Corentec Co., Ltd.	accessdata.fda.gov
August 1, 2024	K242046	EXULT Knee Replacement System	JWH	Substantially Equivalent	Corentec Co., Ltd.	accessdata.fda.gov
March 16, 2023	K223828	BENCOX Delta Option Heads	LZO	Substantially Equivalent	Corentec Co., Ltd.	accessdata.fda.gov
February 27, 2023	K223223	BENCOX Mirabo Z Cup Cortinium	LPH	Substantially Equivalent	Corentec Co., Ltd.	accessdata.fda.gov
August 26, 2022	K222278	LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation	JWH	Substantially Equivalent	Corentec Co., Ltd.	accessdata.fda.gov
May 24, 2022	K210614	BENCOX Mirabo Z Cup Cortinium	LPH	Substantially Equivalent	Corentec Co., Ltd.	accessdata.fda.gov
May 18, 2022	K220468	BENCOX Mirabo Cup System	LPH	Substantially Equivalent	Corentec Co., Ltd.	accessdata.fda.gov
December 9, 2021	K212034	LOSPA TKR System	JWH	Substantially Equivalent	Corentec Co., Ltd.	accessdata.fda.gov
July 14, 2021	K211866	Bencox THR System	LPH	Substantially Equivalent	Corentec Co., Ltd.	accessdata.fda.gov
July 30, 2020	K201851	EXULT Femoral component trial - Left, EXULT Femoral component trial - Right	JWH	Substantially Equivalent	Corentec Co., Ltd.	accessdata.fda.gov
May 7, 2020	K200395	LOSPA II Knee System (EXULT Knee Replacement System)	JWH	Substantially Equivalent	Corentec Co., Ltd.	accessdata.fda.gov
March 6, 2020	K200267	LOSPA® IS Spinal Fixation System	NKB	Substantially Equivalent	Corentec Co., Ltd.	accessdata.fda.gov
December 11, 2019	K192507	LOSPA II Knee System	JWH	Substantially Equivalent	Corentec Co., Ltd.	accessdata.fda.gov
April 1, 2019	K182221	Bencox Mirabo Cup Multi Hole	LPH	Substantially Equivalent	Corentec Co., Ltd.	accessdata.fda.gov
October 17, 2017	K172806	Bencox Mirabo Cup System	LPH	Substantially Equivalent	Corentec Co., Ltd.	accessdata.fda.gov
March 31, 2017	K170243	LOSPA IS TLIF & DLIF Cages	MAX	Substantially Equivalent	Corentec Co., Ltd.	accessdata.fda.gov
January 5, 2017	K161641	LOSPA IS ACP System	KWQ	Substantially Equivalent	Corentec Co., Ltd.	accessdata.fda.gov
December 5, 2016	K162127	Bencox M Stem Lateralized & Bencox Mirabo Cup System	LPH	Substantially Equivalent	Corentec Co., Ltd.	accessdata.fda.gov
December 1, 2016	K160157	LOSPA Modular Knee System	JWH	Substantially Equivalent	Corentec Co., Ltd.	accessdata.fda.gov
April 29, 2016	K152084	Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug	LPH	Substantially Equivalent	Corentec Co., Ltd.	accessdata.fda.gov
October 2, 2015	K151408	LOSPA IS Spinal System	MAX	Substantially Equivalent	Corentec Co., Ltd.	accessdata.fda.gov
May 4, 2015	K150007	Modified Bencox Hip System	LPH	Substantially Equivalent	Corentec Co., Ltd.	accessdata.fda.gov
September 19, 2013	K132644	LOSPA IS PEDICLE SCREW (MONOAXIAL & POLYAXIAL), LOSPA IS ROD- STRAIGHT (STANDARD), LOSPA IS ROD- PRE BENT (STANDARD & BU	MNI	Substantially Equivalent	Corentec Co., Ltd.	accessdata.fda.gov
April 15, 2013	K130673	LOSPA TOTAL KNEE REPLACEMENT SYSTEM	JWH	Substantially Equivalent	Corentec Co., Ltd.	accessdata.fda.gov
October 5, 2012	K122099	BENCOX II STEM, BENCOX METAL HEAD	LPH	Substantially Equivalent	Corentec Co., Ltd.	accessdata.fda.gov
September 25, 2012	K121665	BENCOX FORET & BENCOX DELTA	LZO	Substantially Equivalent	Corentec Co., Ltd.	accessdata.fda.gov
September 10, 2012	K120924	BENCOX MIRABO CUP BENCOX MIRABO INSERT (STANDARD& ELEVATED TYES) BENCOX MIRABO CUP SCREW HOLE PLUG	LPH	Substantially Equivalent	Corentec Co., Ltd.	accessdata.fda.gov
May 3, 2012	K121037	LOSPA TIBIAL BASE PLATE	JWH	Substantially Equivalent	Corentec Co., Ltd.	accessdata.fda.gov
February 16, 2012	K110404	EAUM TOTAL KNEE SYSTEM	JWH	Substantially Equivalent	Corentec Co., Ltd.	accessdata.fda.gov
October 12, 2011	K112019	BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP	KWY	Substantially Equivalent	Corentec Co., Ltd.	accessdata.fda.gov
July 21, 2011	K103431	COREN TOTAL HIP SYSTEM	LPH	Substantially Equivalent	Corentec Co., Ltd.	accessdata.fda.gov
April 2, 2010	K092076	AEGIS & AEGIS II SPINAL SYSTEM	MNI	Substantially Equivalent	Corentec Co., Ltd.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
March 29, 2024	94380	Class II	Ongoing	LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Description: Tibial Insert	Due to unsupported 10 year expiration date.	accessdata.fda.gov
February 27, 2017	76587	Class II	Terminated	Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343	Lot may contain the wrong instruction (Instruction for Chinese customer) instead of correct US instructions for use.	accessdata.fda.gov

Compare with other makers

Updated April 17, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.