FDA Registration
Active
🇯🇵 Japan
MEDMETALEX CO., LTD.
Reg #: 3021723305
·
FEI: 3021723305
·
Expires 2026
Products
16
Proprietary Names
118
Establishment Types
2
Classifications
16
Registration Details
- Registration Name
- MEDMETALEX CO., LTD.
- Registration Number
- 3021723305
- FEI Number
- 3021723305
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4-3-29 Mitejima, Nishiyodogawa-ku
- City
- Osaka
- Country
- JP
Owner / Operator
- Firm Name
- Medmetalex Co., Ltd.
- Operator Number
- 10084378
- Address
- 4-3-29 Mitejima, Nishiyodogawa-ku
- City
- Osaka
- State
- JP-27
- Postal Code
- 5550012
- Country
- JP
- Correspondent
- MOTOHIRO IKOMA
US Agent
- Business Name
- GLOBIZZ CORPORATION
- Contact Name
- Takahiro Haruyama
- Address
- 970 W. 190th St. Suite 200
- City
- Torrance
- State
- CA
- ZIP
- 90502
- Country
- US
- [email protected]
- Phone
- 310 5383833
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2023-04-17 |
| General Purpose Instrument Tray | PXV | Class 1 | General, Plastic Surgery | No | 2023-04-19 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2024-01-22 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2022-02-15 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2023-05-17 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2023-08-09 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2024-01-22 |
| Table And Attachments, Operating-Room | BWN | Class 1 | General, Plastic Surgery | No | 2023-09-29 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2024-04-24 |
| Template | HWT | Class 1 | Orthopedic | No | 2024-01-16 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2023-03-29 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2023-09-29 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2024-03-15 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2023-05-17 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2023-12-25 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2024-02-01 |
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
ACETABULAR SHELL TRIAL, 58MM
ACETABULAR LINER TRIAL (FLAT), 32MM, C
FEMORAL HEAD TRIAL, 32MM, +4MM, L
FEMORAL HEAD TRIAL, 32MM, -4MM, S
FEMORAL HEAD TRIAL, 36MM, +0MM, M
FEMORAL HEAD TRIAL, 32MM, +10MM, XXL
ACETABULAR SHELL TRIAL, 56MM
ACETABULAR LINER TRIAL (HOODED OFFSET), 28MM, A
FEMORAL HEAD TRIAL, 28MM, +0MM, M
ACETABULAR LINER TRIAL (OFFSET), 40MM, E
FEMORAL HEAD TRIAL, 36MM, +4MM, L
ACETABULAR LINER TRIAL (HOODED), 36MM, C
ACETABULAR SHELL TRIAL, 62MM
ACETABULAR SHELL TRIAL, 60MM
FEMORAL HEAD TRIAL, 28MM, +10MM, XXL
ACETABULAR SHELL TRIAL, 52MM
ACETABULAR LINER TRIAL (OFFSET), 36MM, C
ACETABULAR SHELL TRIAL, 50MM
FEMORAL NECK TRIAL (HIGH OFFSET)
ACETABULAR LINER TRIAL (OFFSET), 36MM, D
FEMORAL HEAD TRIAL, 36MM, +12MM, XXL
ACETABULAR SHELL TRIAL, 64MM
FEMORAL HEAD TRIAL, 28MM, +7MM, XL
ACETABULAR LINER TRIAL (FLAT), 40MM, D
ACETABULAR SHELL TRIAL, 46MM
ACETABULAR LINER TRIAL (HOODED), 28MM, A
FEMORAL HEAD TRIAL, 36MM, -4MM, S
FEMORAL HEAD TRIAL, 40MM, -4MM, S
ACETABULAR LINER TRIAL (HOODED OFFSET), 32MM, B
FEMORAL HEAD TRIAL, 32MM, +7MM, XL
FEMORAL HEAD TRIAL, 40MM, +12MM, XXL
ACETABULAR SHELL TRIAL, 54MM
FEMORAL HEAD TRIAL, 28MM, +3.5MM, L
ACETABULAR LINER TRIAL (HOODED), 32MM, B
ACETABULAR LINER TRIAL (HOODED OFFSET), 36MM, C
FEMORAL HEAD TRIAL, 40MM, +8MM, XL
FEMORAL HEAD TRIAL, 36MM, +8MM, XL
ACETABULAR LINER TRIAL (FLAT), 32MM, B
ACETABULAR LINER TRIAL (OFFSET), 40MM, D
ACETABULAR LINER TRIAL (HOODED OFFSET), 44MM, F
ACETABULAR LINER TRIAL (FLAT), 40MM, E
FEMORAL NECK TRIAL (STANDARD OFFSET)
FEMORAL HEAD TRIAL, 40MM, +0MM, M
ACETABULAR LINER TRIAL (OFFSET), 32MM, C
ACETABULAR SHELL TRIAL, 42MM
ACETABULAR LINER TRIAL (FLAT), 36MM, C
ACETABULAR SHELL TRIAL, 44MM
ACETABULAR LINER TRIAL (HOODED), 40MM, D
ACETABULAR LINER TRIAL (HOODED), 40MM, E
ACETABULAR LINER TRIAL (OFFSET), 28MM, A
FEMORAL HEAD TRIAL, 28MM, -3.5MM, S
ACETABULAR LINER TRIAL (HOODED), 32MM, C
FEMORAL HEAD TRIAL, 40MM, +4MM, L
ACETABULAR LINER TRIAL (HOODED OFFSET), 40MM, D
FEMORAL HEAD TRIAL 26MM, +0MM, M
ACETABULAR LINER TRIAL (HOODED), 36MM, D
ACETABULAR LINER TRIAL (FLAT), 36MM, D
ACETABULAR LINER TRIAL (FLAT), 28MM, A
ACETABULAR LINER TRIAL (HOODED OFFSET), 36MM, D
ACETABULAR LINER TRIAL (HOODED OFFSET), 40MM, E
ACETABULAR LINER TRIAL (OFFSET), 32MM, B
FEMORAL HEAD TRIAL, 32MM, +0MM, M
ACETABULAR LINER TRIAL (HOODED OFFSET), 32MM, C
ACETABULAR SHELL TRIAL, 48MM
LexCALIPER
FEMORAL HEAD SIZE GAUGE
LexBLADE
MALLET(SLIT)
FLEXIBLE DRILL SHAFT
STRAIGHT DRILL SHAFT
Bosatsu DRILL
ACETABULAR LINER IMPACTOR HEAD, 28MM
ACETABULAR LINER IMPACTOR HEAD, 32MM
FEMORAL HEAD IMPACTOR(SIDE)
ACETABULAR LINER IMPACTOR HEAD, 36MM
FEMORAL HEAD IMPACTOR
ACETABULAR LINER IMPACTOR HEAD, 40MM
STARTER AWL(HANDLE COLOR BLACK)
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)