BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Zimmer Biomet G.K.

    Reg #: 3012725451 · FEI: 3012725451 · Expires 2026
    View on FDA
    Products
    46
    Proprietary Names
    34
    Establishment Types
    1
    Classifications
    46

    Registration Details

    Registration Name
    Zimmer Biomet G.K.
    Registration Number
    3012725451
    FEI Number
    3012725451
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    6-15 Shinmachi
    City
    Hiratsuka Kanagawa
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K110400

    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 W Center St
    City
    Warsaw
    State
    IN
    ZIP
    46580
    Country
    US
    Email
    [email protected]
    Phone
    715 9289253

    Products

    Device Name Product Code
    Osteotome HWM
    Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQG
    Prosthesis, Hip, Hemi-, Femoral, Metal KWL
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) JDL
    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 Uncemented Acetabular Component) KWA
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Saw HSO
    Forceps HTD
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish MAY
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer MBV
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Mixer, Cement, For Clinical Use JDZ
    Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented OQI
    Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented OQH
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive PBI
    File HTP
    Gouge, Surgical, General & Plastic Surgery GDH
    Impactor HWA
    Pliers, Surgical HTC
    Rongeur HTX
    Caliper KTZ
    Bender HXW
    Tape, Measuring, Rulers And Calipers FTY
    Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KRO
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Gauge, Depth HTJ
    Curette HTF
    Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer HRY
    Skid, Bone HWO
    Forceps, Wire Holding HYA
    Hook, Surgical, General & Plastic Surgery GDG
    Plate, Fixation, Bone HRS
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous MBL
    Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal KWB
    Prosthesis, Hip, Hemi-, Femoral, Metal Ball LZY
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented MBF

    Proprietary Names

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

    Establishment Types

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