BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Zimmer Biomet Korea Ltd.

    Reg #: 3015542154 · FEI: 3015542154 · Expires 2026
    View on FDA
    Products
    108
    Proprietary Names
    63
    Establishment Types
    1
    Classifications
    108

    Registration Details

    Registration Name
    Zimmer Biomet Korea Ltd.
    Registration Number
    3015542154
    FEI Number
    3015542154
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    5F, Ilshin Building, 98 Hannamdae-ro, Yongsan-gu
    City
    Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K882831
    PMA Number
    P060037

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

    Proprietary Names

    BIOMET IMPACTOR Biomet Modular Femoral Revision System G7 Acetabular System Comprehensive® Reverse Shoulder TAPE, MEASURING, RULERS AND CALIPERS FORCEPS ANA0TOMICAL SHOULDER TM COMBINED SYSTEM Comprehensive Humeral Fracture Biomet Knee Joint Replacement Prostheses Biomet Variable Pitch Compression Screw System ROSA® Knee System EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage Cables Vanguard XP Knee System Vanguard 360 Revision Knee System QuattroTm Link Knotless Anchor BIOMET OSTEOTOME Bi-Metric CoCr Head/Neck Replacement Hip Stems ALLthread™ Titanium Suture Anchor INTERMEDICS HIGH TIBIAL OSTEOTOMY SYSTEM BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTS Taperloc Complete Size 4mm and XR 123 AFX® Femoral Implant with Inserter TaperLoc Complete NON-STERILE ZIMMER PLATES AND SCREWS SYSTEM MeshGraft II Pulsavac Plus Biolox® delta Option Ceramic Heads BIOMET FILE BENDER THE NATURAL-KNEE REVISION Titanium Interference Screws LORENZ PECTUS SUPPORT BAR STABILIZER A. L. P. S. Clavicle Plating System Zimmer BIOMET DEPTH; GAUGE; Gauge Biomet Depth X-SERIES BI-METRIC HIP FEMORAL COMPONENTS PLIERS, SURGICAL MALLOY/HEAD LATERALIZED PRESS-FIT FEMORAL Lateralized Taperloc® Microplasty™ Femoral Components Taperloc Complete Microplasty System Pioneer ZCS Cannulated Screw System by Pionee HOOK, SURGICAL, GENERAL & PLASTIC SURGERY CuffLinkTm Suture Anchor Comprehensive Shoulder System Taper 2™ Porous Femoral Stem Taperloc Complete, Sizes 5mm and 6mm Mallory/Head Calcar Replacement with Interlocking Slots Bi-Metric Porous Collared Stem with Interlocking Slots Persona Partial Knee System Comprehensive® Primary Shoulder Stems ToggleLocTM System Prolong Highly Crosslinked Poly Cru XR-Series Bi-Metric® Femoral Components VANGUARD 360 OSSEOTI TIBIAL SLEEVE AUGMENT CALIPER Zimmer NexGen Tibial and Femoral Augments Dual Port/Single Bladder Disposable Cuff Orthopedic Salvage System - OSS BIOMET CEMENT; MIXER Curette RONGUER; STRAIGHT RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM

    Establishment Types

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