FDA Registration
Active
🇨🇳 China
LX PRECISION SHANGHAI CO LTD
Reg #: 3008791302
·
FEI: 3008791302
·
Expires 2026
Products
19
Proprietary Names
63
Establishment Types
1
Classifications
19
Registration Details
- Registration Name
- LX PRECISION SHANGHAI CO LTD
- Registration Number
- 3008791302
- FEI Number
- 3008791302
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.8, Lane 88, Yuanshan Rd., Minhang Dist.
- City
- Shanghai
- Country
- CN
Owner / Operator
- Firm Name
- LX PRECISION SHANGHAI CO LTD
- Operator Number
- 10034962
- Address
- No.8 & 5, Lane 88, Yuanshan Rd., Minhang Dist.
- City
- Shanghai
- State
- CN-SH
- Postal Code
- 201108
- Country
- CN
US Agent
- Business Name
- Emergo Global Representation LLC
- Contact Name
- Yong Sun
- Address
- 2500 Bee Cave Rd., Bldg. 1, Ste. 300
- City
- Austin
- State
- TX
- ZIP
- 78746
- Country
- US
- [email protected]
- Phone
- 512 3279997
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2025-06-11 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2023-11-06 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2016-09-09 |
| Bed, Pediatric Open Hospital | FMS | Class 2 | General Hospital | No | 2023-11-24 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2011-01-20 |
| Device, Fixation, Proximal Femoral, Implant | JDO | Class 2 | Orthopedic | No | 2024-11-05 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2024-11-05 |
| Plate, Bone | JEY | Class 2 | Dental | No | 2019-07-01 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2023-11-23 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2024-11-05 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | MBF | Class 2 | Orthopedic | No | 2016-09-09 |
| Screw, Fixation, Intraosseous | DZL | Class 2 | Dental | No | 2019-08-22 |
| Nail, Fixation, Bone | JDS | Class 2 | Orthopedic | No | 2024-11-05 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2011-01-25 |
| Plate, Fixation, Bone, Non-Spinal, Metallic | NDF | Class 2 | Orthopedic | No | 2016-09-09 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2026-05-18 |
| Plate, Cranioplasty, Preformed, Alterable | GWO | Class 2 | Neurology | No | 2019-07-01 |
| Fastener, Plate, Cranioplasty | HBW | Class 2 | Neurology | No | 2019-07-01 |
| Cover, Burr Hole | GXR | Class 2 | Neurology | No | 2019-07-01 |
Proprietary Names
Biomet 3i Abutment Retaining Screws
ACE CANNULATED CORTICAL BONE SCREW
Biomet Lumbar Plate System
Zimmer Biomet
RAPIDFIRE SELF DRILLING SCREWS
Neuro System
1.5mm System
1mm System
2mm System
CMF System
FBI® OptiLock® Periarticular Plating System
TraumaOne System
EBI® Periarticular Plating System
ACE CANCELLOUS BONE SCREW
EBI® OptiLock Upper Extremity Plating System
EBI VueLockTM Anterior Cervical Plate System
BIOMET 3i Dental Abutments
EBI DFS® Joint Fixator
2X9MM SD IMF SCREW
2X11MM SD IMF SCREW
2X7MM SD IMF SCREW
2X5MM SD IMF SCREW
LORENZ SELF DRILLING SCREWS
TRAUMA INTERNAL FIXATION SYSTEMS
Biomet Headless Compression and Twist-off Screws
BioDrive® Cannulated Screw System
Biomet® Tibial Locking Nail System
EBI Anterior Cervical Plate System
Smith & Nephe Bone Plate System
Biomet Microfixation OmniMax MMF System
Cann Cort Bone Screw
C-Tek® MaxAnTM Anterior Cervical Plate System
2X9MM T1 SD IMF SCREW
2X15MM IMF SCREW
2 X 13MM IMF SCREW
2X11MM T1 SD IMF SCREW
2X7MM T1 SD IMF SCREW
Biomet® Femoral Locking Nail System
EBI® Distal Radius Plating System
Affixus® Natural Nail® System Humeral Nail
3MM BIOMET CANNULATED SCREW SYSTEM
EBI® XFIX® Vision® Fixation System
Affixus Humeral Stem
GENESIS II
EBI X FIX DYNAFIX SYSTEM (DFS)
ACE CORTICAL LAG SCREW
OptiLock® VL Distal Radius Plating System
1.5X4MM X-DRIVE TF SD SCREW
1.65 X 6MM SD X-DRIVE SCREW
1.5X3.5MM X-DRIVE TF SD SCREW
1.5X5MM HT SD X-DR SCR
1.65X5MM HT SD X-DR SCR
1.5X4MM HT SD X-DR SCR
1.5X7MM HT SD X-DR SCR
1.65 X 7MM HT SD X-DRIVE
1.5X6MM HT SD X-DR SCR
1.5X3.5MM HT SD X-DR SCR
BIOMET CANNULATED SCREW SYSTEM
N/A
Biomet Microfixation Neuro Plating System
CranioCurve
EBI XFIX® DFS® Rail System
-
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)