Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021723305

FEI Number

3021723305

Entity Name

MEDMETALEX CO., LTD.

City/State/Country

Osaka, JP

Establishment Address

4-3-29 Mitejima, Nishiyodogawa-ku, Osaka 5550012, JP

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Medmetalex Co., Ltd. (Owner Number: 10084378)

Owner / Operator Contact Address

4-3-29 Mitejima, Nishiyodogawa-ku, Osaka, JP-27 5550012, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ACETABULAR SHELL / LINER IMPACTOR (STRAIGHT) LexTOME Acetabular Reamer Straight Handle LexTOME Acetabular Reamer Offset Handle FEMORAL STEM EXTRACTOR (NECK HOLD) SLIDE HAMMER(SLIT) FEMORAL STEM INSERTER SHAFT (STRAIGHT 2) FEMORAL STEM INSERTER SHAFT (OFFSET) FEMORAL HEAD EXTRACTOR ACETABULAR SHELL / LINER IMPACTOR (OFFSET) SKIN PROTECTOR T-SHAPED HANDLE ALIGNMENT ROD MODULAR HANDLE ACETABULAR SHELL / LINER IMPACTOR (OFFSET)CAS STRAIGHT DRIVER SHAFT FEMORAL STEM INSERTER SHAFT (STRAIGHT 1) LexTOME ACETABULAR REAMER CONTAINER MODULAR BOX OSTEOTOME LexTOME Acetabular Reamer Set GREATER TROCHANTER REAMER CALCAR PLANER STARTER REAMER (STRAIGHT) DRII GUIDE(STRAIGHT) ALIGNMENT GUIDE (LATERAL) DRILL GUIDE(OFFSET) ALIGNMENT GUIDE (SUPINE) NECK RESECTION GUIDE FEMORAL HEAD REMOVER BIPOLAR CUP EXTRACTOR, 28MM FEMORAL STEM EXTRACTOR (SCREW) BIPOLAR CUP EXTRACTOR, 22MM LexTORNADO ACETABULAR LINER EXTRACTOR FEMORAL HEAD TRIAL EXTRACTOR FEMORAL HEAD TRIAL EXTRACTOR TYPE1 FEMORAL HEAD TRIAL EXTRACTOR TYPE2 BIPOLAR CUP EXTRACTOR, 26MM DEPTH GAUGE Quick Arm FORCEPS FOR C RINGS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2023-04-17
PXV	General Purpose Instrument Tray	General, Plastic Surgery	Class 1	878.4800	2023-04-19
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	2024-01-22
HTO	Reamer	Orthopedic	Class 1	888.4540	2022-02-15
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2023-05-17
HWB	Extractor	Orthopedic	Class 1	888.4540	2023-08-09
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2024-01-22
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2023-09-29
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2024-04-24

Official Correspondent

MOTOHIRO IKOMA

US Agent Details

Takahiro Haruyama Business: GLOBIZZ CORPORATION Email: register@globizz.net Phone: (310) 5383833

Related Public Records

Same Entity

Medmetalex 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
K812396	Northwest Surgical Concepts, Inc.	ARTHRO-PREP REST	1981-11-20
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

Similar Registrations

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3021574846	3D LOGICS LLC	Hillsboro, OR, US
3030089866	ORTOLOG MEDIKAL SANAYI VE TICARET A.S.	Yenimahalle Ankara, TR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021723305. Last updated year: 2026. Please use registration number 3021723305 when referencing this establishment in official correspondence.