Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021519357

FEI Number

3021519357

Entity Name

CnS MEDICAL CO., LTD.

City/State/Country

Pocheon-si Gyeonggi, KR

Establishment Address

94-40 Yongjeonggyeongje-ro 1-gil, Gunnae-myeon, Pocheon-si, Gyeonggi-do, Republic of Korea, Pocheon-si Gyeonggi 11154, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CnS MEDICAL Co., Ltd. (Owner Number: 10089381)

Owner / Operator Contact Address

94-40 Yongjeonggyeongje-ro 1-gil, Gunnae-myeon, Pocheon-si, Gyeonggi-do, Republic of Korea, Pocheon-si, KR-41 11154, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Endo Spade Knife Spade Knife eX Cage Impactor F Endo Cage Impactor Bone Chip Cannula & Impactor Prep Reamer T Prep Reamer Prep Reamer Handle Osteotome Endo Cutting Forcep Short Endo Cutting Forcep Long Micro Pituitary Pituitary 2 - Straight Type Fan Dissector Prep Dissector - Straight Type Muscle Detacher - T-Bar Endo Cob Dissector Prep Dissector - Fan Type Endo Dissector - Curved Type CVD Dilator - MHSD-Bar Prep Dissector - Curved Type Double Ended Dissector Endo Prep. Dissector HA Delivery Tube EW-1, ES-1 Scope Cannula Self-Retractor Working Cannula Single Working Cannula Transparent Serial Dilator Mallet Foraminal CVD Kerrsion Punch Kerrsion Punch Rotatory K-Punch Rotatory Foraminal CVD K-Punch Dura Suture Pusher Curette

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTS	Knife, Orthopedic	Orthopedic	Class 1	888.4540	2026-04-22
HWA	Impactor	Orthopedic	Class 1	888.4540	2026-04-22
HTO	Reamer	Orthopedic	Class 1	888.4540	2026-04-22
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2026-04-22
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2026-04-22
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2026-04-22
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2024-08-05
GCC	Dilator, Catheter	General, Plastic Surgery	Class 1	878.4200	2026-04-22
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2026-04-22
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2026-04-22
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	2026-04-22
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2026-04-22

Official Correspondent

SANGCHANG PARK

US Agent Details

Jung Ryun Ahn Business: KMC USA, Inc Email: kmc.usa@kmcerti.com Phone: (646) 3576058

Related Public Records

Same Entity

CnS MEDICAL Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K851170	The Huxley Instrument Corp.	DISSECTING TWEEZER #283-72PCS. SS 410	1985-04-25
K821248	Conphar, Inc.	ROCHESTER PEAN FORCEPS	1982-05-28
K863293	Lifestream Int'L, Inc.	DISPOSABLE SUCTION CANNULA NO. 902008-000	1986-09-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2008	N/A	1	EPIK KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.
Z-0021-2015	Biomet, Inc.	1	Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.
Z-0034-2012	X Spine Systems Inc	1	Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050, Mfr. By: Bradshaw Medical Inc., Kenosha, WI 53144 The Axle Torque Driver Handle is used to lock the set screw into the locking plate.

Similar Registrations

Registration Number	Establishment Name	Location
3027262786	SOLENDOS., INC.	GURO-GU Seoul, KR
8010733	PRO-MED INSTRUMENTE GMBH	TUTTLINGEN Baden-Wurttemberg, DE
9613910	NARANG MEDICAL, LTD.	New Delhi, IN
8010155	A.HANDTE MEDIZINTECHNIK GMBH & CO. KG	TUTTLINGEN Baden-Wurttemberg, DE
3015259876	B-ONE ORTHO, CORP.	Cedar Knolls, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021519357. Last updated year: 2026. Please use registration number 3021519357 when referencing this establishment in official correspondence.