BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    Zimmer Biomet Pty Ltd

    Reg #: 3035366890 · FEI: 3035366890 · Expires 2026
    View on FDA
    Products
    102
    Proprietary Names
    40
    Establishment Types
    1
    Classifications
    102

    Registration Details

    Registration Name
    Zimmer Biomet Pty Ltd
    Registration Number
    3035366890
    FEI Number
    3035366890
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Level 4, 12 Narabang Way, Belrose, NSW
    City
    Sydney New South Wales
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K935789
    PMA Number
    N17755

    Owner / Operator

    Firm Name
    Zimmer Biomet APAC DFE
    Operator Number
    10056128
    Address
    Unit 01-10,19/F, Metro Plaza 555 Lou Shan Guan Road, Changning District
    City
    Shanghai
    State
    CN-SH
    Postal Code
    200051
    Country
    CN

    US Agent

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

    Products

    Device Name Product Code
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Screw, Fixation, Bone HWC
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Pin, Fixation, Smooth HTY
    Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented OQI
    Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented OQH
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish MAY
    Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQG
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Rod, Fixation, Intramedullary And Accessories HSB
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Prosthesis, Hip, Hemi-, Femoral, Metal KWL
    Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) JDL
    Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) KWA
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer MBV
    Plate, Fixation, Bone HRS
    Pin, Fixation, Threaded JDW
    Neurological Stereotaxic Instrument HAW
    Fastener, Fixation, Biodegradable, Soft Tissue MAI
    Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained JWJ
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented MBF
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite LXT
    Shoulder Prosthesis, Reverse Configuration PHX
    Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KRO
    Forceps HTD
    Cerclage, Fixation JDQ
    Retention Device, Suture KGS
    Washer, Bolt Nut HTN
    Bone Cement LOD
    Caliper KTZ
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Expander, Surgical, Skin Graft FZW
    Staple, Fixation, Bone JDR
    Prosthesis, Elbow, Constrained, Cemented JDC
    Prosthesis, Elbow, Semi-Constrained, Cemented JDB
    Prosthesis, Hip, Semi-Constrained, Composite/Metal KMC
    Laparoscope, General & Plastic Surgery GCJ
    Arthroscope HRX
    Forceps, Wire Holding HYA
    Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer HRY
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Clip, Implantable FZP
    Marker, Radiographic, Implantable NEU
    Applier, Cerclage HXN
    Prosthesis, Hip, Femoral Component, Cemented, Metal JDG
    Instrument, Surgical, Sonic And Accessory/Attachment JDX
    Nail, Fixation, Bone, Metallic NDH
    Plate, Fixation, Bone, Non-Spinal, Metallic NDF
    Posterior Metal/Polymer Spinal System, Fusion NQP
    Prosthesis, Hip, Femoral, Resurfacing KXA
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous MBL
    Prosthesis, Toe, Constrained, Polymer KWH
    Gauge, Depth HTJ
    Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment HSZ
    Prosthesis, Hip, Hemi-, Femoral, Metal Ball LZY
    Cement Obturator LZN
    Mixer, Cement, For Clinical Use JDZ
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    Suture, Nonabsorbable, Synthetic, Polyester GAS
    Component, Traction, Invasive JEC
    Filler, Bone Void, Calcium Compound MQV
    Device, Fixation, Proximal Femoral, Implant JDO
    Pliers, Surgical HTC
    Holder, Needle; Orthopedic HXK
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented PAO
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive PBI
    Gouge, Surgical, General & Plastic Surgery GDH
    Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer KRR
    Suture, Absorbable, Synthetic, Polyglycolic Acid GAM
    Syringe, Piston FMF
    File HTP
    Curette HTF
    Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal KWB
    Nail, Fixation, Bone JDS
    Prosthesis, Elbow, Hemi-, Radial, Polymer KWI
    Skid, Bone HWO
    Bone Cement, Antibiotic MBB
    Gauze/Sponge, Internal EFQ
    Impactor HWA
    Appliance, Fixation, Nail/Blade/Plate Combination, Single Component KTW
    Sterilizer, Chemical MLR
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Lavage, Jet FQH
    Tape, Measuring, Rulers And Calipers FTY
    Rongeur HTX
    Sterilizer, Steam FLE
    Hook, Surgical, General & Plastic Surgery GDG
    Osteotome HWM
    Bender HXW
    Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer NJD
    Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented MJT
    Saw HSO

    Proprietary Names

    XR-Series Bi-Metric® Femoral Components Taperloc Complete Size 4mm and XR 123 ANA0TOMICAL SHOULDER TM COMBINED SYSTEM Taperloc Complete Microplasty System RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM FORCEPS CALIPER MeshGraft II Zimmer MALLOY/HEAD LATERALIZED PRESS-FIT FEMORAL X-SERIES BI-METRIC HIP FEMORAL COMPONENTS BIOMET DEPTH; GAUGE; Gauge Biomet Depth Taperloc Complete, Sizes 5mm and 6mm Biolox® delta Option Ceramic Heads BIOMET CEMENT; MIXER Vanguard XP Knee System TaperLoc Complete Pioneer ZCS Cannulated Screw System by Pionee PLIERS, SURGICAL Biomet Knee Joint Replacement Prostheses G7 Acetabular System Comprehensive® Primary Shoulder Stems Biomet Modular Femoral Revision System INTERMEDICS HIGH TIBIAL OSTEOTOMY SYSTEM BIOMET FILE Curette Taper 2™ Porous Femoral Stem BIOMET IMPACTOR Bi-Metric CoCr Head/Neck Replacement Hip Stems Orthopedic Salvage System - OSS NON-STERILE ZIMMER PLATES AND SCREWS SYSTEM Lateralized Taperloc® Microplasty™ Femoral Components Pulsavac Plus THE NATURAL-KNEE REVISION TAPE, MEASURING, RULERS AND CALIPERS RONGUER; STRAIGHT HOOK, SURGICAL, GENERAL & PLASTIC SURGERY BIOMET OSTEOTOME BENDER

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device