Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004176895

FEI Number

3004176895

Entity Name

BK MEDITECH CO., LTD.

City/State/Country

Hwaseong-si Gyeonggi, KR

Establishment Address

58, Eunhaengnamu-ro, Yanggam-myeon, Hwaseong-si Gyeonggi 18633, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BK MEDITECH CO., LTD. (Owner Number: 9059102)

Owner / Operator Contact Address

58, Eunhaengnamu-ro, Yanggam-myeon, --, Hwaseong-si, KR-41 18633, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K200981

PMA Number

N/A

All Registered Proprietary Names

SHAVER RASP INNESIS PEEK CAGE MEGA SPINE SYSTEM SURGICAL INSTRUMENT TRAY CALIPERS MEGA PLUS SPINE SYSTEM LONG-ARM BREAKER TAB BREAKER STRAIGHT PROBE BENT PROBE STRAIGHT PROBE(LENKE) BENT PROBE(LENKE) CANNULATED PROBE MEGA PLUS SPINE SYSTEM Dyna-EXTOR II External Fixation System MEGA5.5 SPINE SYSTEM ROD INTRODUCER ROD PUSHER ROD ROCKER FINAL WRENCH(4.5MM) PICK-UP WRENCH(5MM) 3.5MM FINAL TIGHTENER FINAL WRENCH(5MM) WRENCH 3(3MM HEX) PICK-UP WRENCH(4.5MM) DOUBLE STARTER FINAL WRENCH(BT20) REDUCER T-WRENCH DUAL LOCKING WRENCH PICK-UP WRENCH FINAL WRENCH(BT30) MIS Final Wrench(BT20) MIS Dual Locking Wrench MIS Final Wrench(BT30) INNESIS PEEK CERVICAL CAGE MULTI-AXIAL SCREW DRIVER ALIGNMENT DRIVER MONO SCREW DRIVER LONG-ARM SCREW DRIVER LONG-ARM MULTI-AXIAL SCREW DRIVER DISTRACTION SCREW DRIVER TURNBUCKLE DRIVER-FIXED SCREW DRIVER INTERMEDIATE SCREW DRIVER ILIAC SCREW DRIVER CANNULATED ADJUST DRIVER MIS SCREW DRIVER REDUCTION INTRODUCER GUIDE PIN(L) ROD GRIPPER GUIDE PIN(R) ANTI TORQUE DRIVER I-TYPE RATCHET HANDLE T-TYPE RATCHET HANDLE PERSUADER SQ-ADAPTER HANDLE TESTER CAGE SUPPORT GRAFT CASE BONE FILLER TRIAL DISTRACTION SCREW EXTRACTOR ANTI TORQUE BALL POINT TESTER LEFT MARKER RIGHT MARKER 4 SIDED I-RATCHET HANDLE REDUCER MINI T-RATCHET HANDLE LARGE T-TORQUE HANDLE DISTRACTOR SPINNER REDUCER STICK DEROTATOR HANDLE ROTATION HANDLE ROTATION TUBE SPANNER DEROTATION CLIP CLIP WRENCH RELEASE T-BLOCK ONE-STEP MIS DRIVER SC REDUCER TAB ALIGNMENT SMALL DILATOR FASCIA CUTTER LARGE DILATOR MEDIUM DILATOR ANTI TORQUE SLEEVE LINKAGE HANDLE DEROTATOR LINKAGE WIRE HOLDER ROD HOLDER INTER LINK CROSS BAR T-TORQUE HANDLE INJECTOR WRENCH INNER ANTI TORQUE GUIDE WIRE LONG ROD INSERTER OUTER RING DYE INJECTOR INTER LINK ANTI TORQUE HANDLE LONG TAB PROTECTOR AWL CANNULATED AWL Prase-C Anterior Cervical Plate System TAP CANNULATED TAP PIN SCREW HAKI Knife DVX5.5 SPINE SYSTEM COMPRESSOR BALL CURETTE GRAFT IMPACTOR STRAIGHT IMPACTER FINAL IMPACTOR IMPACTOR GRAFT INSERTER INSERTER CURVED IMPACTER ROD BENDER FRENCH ROD BENDER MEGA PLUS MIS SPINE SYSTEM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2013-11-17
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2013-03-13
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2008-01-02
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2008-01-02
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-11-17
KTZ	Caliper	Orthopedic	Class 1	888.4150	2020-09-18
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2019-09-20
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-11-17
HXB	Probe	Orthopedic	Class 1	888.4540	2008-07-02
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2018-03-18
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2012-07-02
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-03-13
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-03-13
HXO	Pusher, Socket	Orthopedic	Class 1	888.4540	2008-07-02
HXC	Wrench	Orthopedic	Class 1	888.4540	2013-11-17
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2014-11-04
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2008-07-02
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2008-07-02
HWJ	Awl	Orthopedic	Class 1	888.4540	2008-07-02
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2024-12-16
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2008-07-02
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2006-07-26
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2008-04-29
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2009-11-25
HWN	Instrument, Compression	Orthopedic	Class 1	888.4540	2008-07-02
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2014-11-04
HWA	Impactor	Orthopedic	Class 1	888.4540	2013-11-17
HXW	Bender	Orthopedic	Class 1	888.4540	2008-07-02
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2020-09-11

Official Correspondent

BYOUNGJUN PARK

US Agent Details

Elaine Duncan Business: Paladin Medical, Inc. Email: Duncan@paladinmedical.com Phone: (715) 5496035

Related Public Records

Same Entity

BK MEDITECH 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
K223430	Life Spine, Inc.	ProLift Micro Expandable Spacer System	2023-05-04
K102293	Globus Medical, Inc.	CALIBER SPACER	2011-01-05
K193541	Nu Vasive, Incorporated	NuVasive Cohere Thoracolumbar Interbody System	2020-03-30
K080401	Advanced Medical Technologies AG	SHELL CAGE, WAVE CAGE, LOOP CAGE	2008-05-09
K200084	Zavation Medical Products, LLC	Zavation IBF System	2020-10-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0001-2013	Synthes USA HQ, Inc.	2	MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
Z-0004-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
Z-0005-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.
Z-0020-06	Pioneer Surgical Technology	2	Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004176895. Last updated year: 2026. Please use registration number 3004176895 when referencing this establishment in official correspondence.