BEUDAMED
    FDA Registration Active 🇨🇳 China

    Changzhou Biomet Medical Devices Co., Ltd.

    Reg #: 3007923096 · FEI: 3007923096 · Expires 2026
    View on FDA
    Products
    54
    Proprietary Names
    157
    Establishment Types
    2
    Classifications
    54

    Registration Details

    Registration Name
    Changzhou Biomet Medical Devices Co., Ltd.
    Registration Number
    3007923096
    FEI Number
    3007923096
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No. 235 Chuangxin Road, EPZ Xinbei District
    City
    Changzhou City Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K082300
    PMA Number
    P010014

    Owner / Operator

    Firm Name
    Biomet, Inc.
    Operator Number
    1825034
    Address
    56 East Bell Dr., PO Box 587
    City
    Warsaw
    State
    IN
    Postal Code
    46582
    Country
    US

    US Agent

    Business Name
    Zimmer Biomet
    Contact Name
    Stephanie Lynch
    Address
    1800 West Center Street
    City
    Warsaw
    State
    IN
    ZIP
    46580
    Country
    US
    Email
    [email protected]
    Phone
    715 9289253

    Products

    Device Name Product Code
    Screw, Fixation, Bone HWC
    Washer, Bolt Nut HTN
    Plate, Fixation, Bone HRS
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish MAY
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) KWA
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
    Prosthesis, Hip, Hemi-, Femoral, Metal KWL
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) JDL
    Shoulder Prosthesis, Reverse Configuration PHX
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Nail, Fixation, Bone JDS
    Rod, Fixation, Intramedullary And Accessories HSB
    Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented OQI
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive PBI
    Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQG
    Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented OQH
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer MBV
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Thoracolumbosacral Pedicle Screw System NKB
    Orthosis, Spinal Pedicle Fixation MNI
    Appliance, Fixation, Spinal Interlaminal KWP
    Plate, Bone JEY
    Prosthesis, Hip, Semi-Constrained, Composite/Metal KMC
    Screw, Fixation, Intraosseous DZL
    Cover, Burr Hole GXR
    Fastener, Plate, Cranioplasty HBW
    Plate, Cranioplasty, Preformed, Alterable GWO
    Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing NRA
    Plate, Cranioplasty, Preformed, Non-Alterable GXN
    Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer HRY
    Template HWT
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented MBF
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite LXT
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Prosthesis, Hip, Femoral Component, Cemented, Metal JDG
    Implant, Endosseous, Root-Form DZE
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented PAO
    Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis OSH
    Pin, Fixation, Smooth HTY
    Pin, Fixation, Threaded JDW
    Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KRO
    Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer KRR

    Proprietary Names

    ANATOMIC LOCKING PLATING SYSTEM ALTRA PRESS-FIT HIP SYSTEM 2.5 MM MULTIDIRECTIONAL THREADED PEGS, MODELS 131211110- 131211130, 1.5 MM LOCKING SCREWS, MODELS 131220408-131220424 COMPREHENSIVE REVERSE SHOULDER-MINI BASEPLATE LORENZ PECTUS SUPPORT BAR, TITANIUM LORENZ PECTUS SUPPORT BAR STABILIZER, TITANIUM Affixus Tibial Nailing System SYSTEM STERNAL CLOSURE BIOMET MICROFIXATION G7 FINNED ACETABULAR SHELL C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM VANGUARD XP KNEE SYSTEM ACE CANNULATED CORTICAL BONE SCREW ACE 8MM CANNULATED CANCELLOUS BONE SCREW NEXT GENERATION KNEE SYSTEM MAXIM ACCEL KNEE SYSTEM POLARIS SPINAL SYSTEM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER LORENZ 1MM, 1.5MM, 2MM SYSTEM MALLORY/HEAD TOTAL HIP SYSTEM LORENZ IMF SCREW NEXTGEN ALTIUS OCT SYSTEM MALLORY/HEAD CALCAR REPLACEMENT WITH INTERLOCKING SLOTS BI-METRIC POROUS COLLARED STEM WITH INTERLOCKING SLOTS Biomet Microfixation OmniMax MMF System Z1 Cemented Hip System SUPPORT BAR LORENZ PECTUS STABILIZER Biomet Proximal Humerus Plating System A. L. P. S. Clavicle Plating System VANGUARD 360 REVISION KNEE SYSTEM MODIFICATION TO ALTIUS OCT SYSTEM MALLORY-HEAD MODULAR CALCAR REPACEMENT COMPONENTS FENNING FEMORAL COMPONENT NEURO PLATING BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM OXFORD MENISCAL UNICOM RAPIDFIRE SELF DRILLING SCREWS SPIN DOWN RAPIDFLAP ANTEROLATERAL AND MEDIAL LOCKING PLATING SYSTEM TRILOGY ACETABULAR SYSTEM TAPERLOC COMPLETE, SIZE 5 AND 6 APF POROUS COATED LINE EXTENSION Zimmer Persona Personalized Knee System Biomet Microfixation RibFix Blu Thoracic Fixation System Biomet Knee Joint Replacement Prostheses TAPERLOC COMPLETE ACE SUPRACONDYLAR PLATE BIOMET BIPOLAR PROSTHESIS Comprehensive® Reverse Shoulder FINE GRAIN CAST COBALT CHROMIUM HIP STEMS ARCPM 1050 RESIN-HIPS OFFSET TIBIAL TRAY Biomet Microfixation SternaLock 360 Sternal Closure System PLATES SYSTEMS MANDIBULAR FRACTURE AND PREBENT RECONSTRUCTION DEVICES BIOMET TEMPLATE RECOVERY PROTRUSIO CAGE G7 FREEDOM AND OFFSET LINERS, FREEDOM HEAD, SIZE 32 FACIAL PLATING SYSTEM VERSA-DIAL HUMERAL HEAD PROSTHESIS DEPUY FRACTURE AND FUSION PLATING SYSTEM BIMETRIC COCR HEAD/NECK REPLACEMENT HIP STEM DVR LATERAL PLATE DVR ULNA PLATE DVR DORSAL PLATE DORSAL NAIL PLATE, ANATOMICAL 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(S STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S BIPOLAR HIP DEVICE MCK MAXIMUM CONGRUENT KNEE) KNEE SYSTEM EBI 5.5 Helical Flange Spinal System DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM ACE CANCELLOUS BONE SCREW MODIFIED DISTAL RADIUS PLATING SYSTEM AGC TOTAL KNEE SYSTEM KNEE, ASCENT TOTAL KNEE SYSTEM, MAXIM COMPLETE KNEE SYSTEM, MAXIM ACCEL KNEE SYSTEM ALSO KNOWN 150MM COCR BIMETRIC HEAD/NECK REPLACEMENT HIP STEM- COLOR BUFF FINISH ACE 3.5MM CORTICAL BONE SCREW MICROPLASTY TIBIAL TRAYS RINGLOC 36MM LINE AND MODULAR FEMORAL HEADS 130 MODIFIED INTEGRAL FEMORAL COMPONENT LATERAL COLUMN LENGTH PLATE, MODEL 824073000-3, LOCKED FUSIO PLATE, MODEL 824077010, COMPRESSION FUSION PLATE, RINGLOC BI-POLAR ACETABULAR COMPONENT Affixus Tibial and Antegrade Femoral Nailing System CONTRAINDICATIONS BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED Taperloc Complete Hip Stem COMPREHENSIVE REVERSE SHOULDER FRAGMENT PLATE SYSTEM PROFILE AND MULTIDIRECTIONAL SCREWS PROXIMAL TIBIA LOCKING PLATE STANDARD AND LARGE, 3.5MM LOW Taperloc® Complete Hip Stems 2.5MM INLINE FUSION PLATE SIZE 4MM & XR 123 INTEGRAL CO-CR FEMORAL COMPONENT LORENZ IMF SCREW SELF-DRILLING POSTERIOR LATERAL PLATES SMALL FRAGMENT LOCKING PLATING SYSTEM TAPERLOC COMPLETE MICROPLASTY STEM Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate NexGen Legacy CCK (L-CCK) NexGen Legacy PS (L-PS) Comprehensive Shoulder System DISTAL RADIUS VOLAR RIM PLATE STANDARD AND NARROW Comprehensive Vault Reconstruction System Biomet Microfixation Thoracic Fixation System SMALL BONE LOCKING PLATING SYSTEM ACE CANNULATED SELF-TAPPING CORTICAL BONE SCREW 6.5MM SOLID CANCELLOUS BONE SCREW DISTAL VOLAR RADIUS PLATING SYSTEMS A.L.P.S. CALCANEAL PLATING SYSTEM SYSTEM (TRAUMAONE) FRACTURE/RECONSTRUCTION BIOMET COBALT-CHROME FEMORAL COMPONENTS Polaris Spinal System MOLDED POLY TIBIA VANGUARD REMOVABLE Biomet Microfixation Sternal Closure System MODULAR PROTUSIO CUP ALTRA FX HIP SYSTEM LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM MAXAN ANTERIOR CERVICAL PLATE SYSTEM TITANIUM LOW PROFILE SCREWS TRAUMA INTERNAL FIXATION SYSTEMS 5.5 HELICAL FLANGE SPINAL SYSTEM, POLARIS COMPONENTS ACE CORTICAL LAG SCREW VERSA-DIAL HUMERAL HEAD DEPUY AE TK2 HIP SCREW SYSTEM ZINDRICK IM ROD ACE CANNULATED SELF TAPPING CANCELLOUS BONE SCREW LORENZ SELF DRILLING SCREWS AGC REVISION KNEE PROTHESIS G7 ACETABULAR SYSTEM VANGUARD COMPLETE KNEE SYSTEM OLECRANON PLATES MODEL 131218704-708; 851318704-708, 1312182 MEDICAL PLATES, LATERAL PLATES, POSTERIOR LATERAL PLATES, Zimmer Knee Joint Replacement Prostheses MR Labeling THE NEW BIO-MOORE ENDO HEADS LAPIDUS PLATE, 3.5MM INLINE FUSION PLATE 3.5MM MTP PLATE (LEFT AND RIGHT) 824677021, 22, 824071001, 824071101, 824671001, 82467 CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021 TAPERLOC FEMORAL STEM AND UNIVERSAL ACETABULAR COM SALVAGE/ONOCOLOGY HIP AND TOTAL FEMUR SYSTEM EBI MAS SPINAL TOP LOADING FIXATION SYSTEM

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)