BEUDAMED
    FDA Registration Active 🇨🇱 Chile

    BIOMET CHILE S.A.

    Reg #: 3014302784 · FEI: 3014302784 · Expires 2026
    View on FDA
    Products
    62
    Proprietary Names
    143
    Establishment Types
    1
    Classifications
    62

    Registration Details

    Registration Name
    BIOMET CHILE S.A.
    Registration Number
    3014302784
    FEI Number
    3014302784
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Av. Santa Clara No. 085 Floor 7, HUECHURABA
    City
    Santiago de Chile Region Metropolitana
    Country
    CL

    Regulatory Submissions

    510(k) Number
    K051975

    Owner / Operator

    Firm Name
    ZimmerBiomet Americas DFE
    Operator Number
    10056779
    Address
    1800 W Center St.
    City
    Warsaw
    State
    IN
    Postal Code
    46580
    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
    Prosthesis, Elbow, Constrained, Cemented JDC
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQG
    Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented OQH
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish MAY
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive PBI
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented OQI
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Femoral Component, Cemented, Metal JDG
    Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KRO
    Cerclage, Fixation JDQ
    Plate, Fixation, Bone HRS
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented MBF
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Screw, Fixation, Bone HWC
    Shoulder Prosthesis, Reverse Configuration PHX
    Bone Cement LOD
    Fastener, Fixation, Biodegradable, Soft Tissue MAI
    Pin, Fixation, Smooth HTY
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite LXT
    Prosthesis, Hip, Hemi-, Femoral, Metal KWL
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer MBV
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Sterilizer, Chemical MLR
    Passer HWQ
    Driver, Prosthesis HWR
    Rod, Fixation, Intramedullary And Accessories HSB
    Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained JWJ
    Starter, Bone Screw HWD
    Prosthesis, Hip, Hemi-, Femoral, Metal Ball LZY
    Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal KWB
    Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) JDL
    Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) KWA
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous MBL
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Pin, Fixation, Threaded JDW
    Instrument, Surgical, Sonic And Accessory/Attachment JDX
    Washer, Bolt Nut HTN
    Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer HRY
    Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer KRR
    Staple, Fixation, Bone JDR
    Prosthesis, Hip, Femoral, Resurfacing KXA
    Template HWT
    Bit, Drill HTW
    Tray, Surgical, Instrument FSM
    Reamer HTO
    Guide, Surgical, Instrument FZX
    Prosthesis, Elbow, Hemi-, Radial, Polymer KWI
    Punch, Femoral Neck HWP
    Screwdriver HXX
    Tap, Bone HWX
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY

    Proprietary Names

    POROUS COATED DISCOVERY ELBOW ARCOS TROCHANTER BUTTON COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES BIOMET ONCOLOGY SALVAGE SYSTEM (OSS) TAPER STACKING ADAPTER BIOMET HUMERAL CABLE PLATES TRILOGY ACETABULAR SYSTEM COMPREHENSIVE HUMERAL FRACTURE SYSTEM WASHERLOC SCREW SYSTEM, LIGAMENT SCREW SYSTEM, NO-PROFILE BI-CORTICAL SCREW SYSTEM, CHANNEL LIGAMENT CLAMP, HECKMAN SCRE ARCPM 1050 RESIN-HIPS COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY COBALT G HV BONE CEMENT LACTOSORB BONE PIN ASTEL NON-METAL BACKED ACETABULAR CUP FOR CEMENTED ARCOMXL POLYETHYLENE LINERS AND BIOLOX DELTA HEADS ZIMMER UNICOMPARTMENTAL KNEE SYSTEM 100KGY E-POLY MAXROM ACETABULAR LINERS NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED (LPS); LPS-FLEX FIXED BEARING FEMORAL AND ARTICULAR SURFACE CO DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM MALLORY/HEAD MODULAR CALCAR WITH AND WITHOUT HA MOORE HIP PROSTHESIS, PMMA COATED ZCH ALPHA SYSTEM TRILOGY ACETABULAR SHELL & LINERS 36MM G7 Dual Mobility System, Active Articulation System MALLORY-HEAD TOTAL HIP SYSTEM ZIMMER M/L TAPER HIP PROSTHESIS MODULAR HYBRID GLENOID EBI OPTILOCK UPPER EXTREMITY PLATING SYSTEM Biomet Tibial trays Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer HARRIS/GALANTE POROUS (HGP) HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING HARRIS-GALANTE POROUS TOTAL HIP SYS ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM COMPREHENSIVE SEGMENTAL REVISION SYSTEM (SRS) BIOMET BIPOLAR PROSTHESIS G7 OSSEOTI ACETUBLAR SHELLS passer driver, prosthesis VERSA-DIAL HUMERAL HEAD PROSTHESIS TAPERLOC 12/14 TAPER FEMORAL COMPONENTS COMPREHENSIVE PRIMARY SHOULDER STEMS UNIVERSAL AND TROCH ENTRY FEMORAL NAILING SYSTEMS LINE EXTENSION PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES UNIVERSAL LOCKING SYSTEM, 3.5MM PLATES AND SCREWS-4936 PLATES,4835 SCREWS OSS MODULAR STEMS, OSS DIAPHYSEAL SEGMENTS HERITAGE HIP SYSTEM OSS-BODIES PROXIMAL TIBIAL SLEEVE CRUCIATE RETAINING (AUGMENTABLE) AND CONSTRAINED CONDYLAR KNEE (CCK) NEXGEN COMPL. KNEE SOL. LEGACY POSTERIOR STABILIZED/CONSTRAINED CONDYLAR KNEE FEMORAL COMPONENTS/ARTICULAR SURFACES NEXT GENERATION KNEE SYSTEM NEXGEN COMPLETE KNEE SOLUTION MAESTRO WRIST FRACTURE IMPLANT RESORBABLE INTERFERENCE SCREW MODIFIED DISTAL RADIUS PLATING SYSTEM DISTAL VOLAR RADIUS PLATING SYSTEMS Starter, Bone Screw TRABECULAR METAL REVISION SHELL LINERS FEMORAL HOOK VANGUARD 360 REVISION KNEE SYSTEM TAPER 2 POROUS FEMORAL STEM POROUS TITANIUM ACETABULAR AUGMENTS ARCOS INTERLOCKING DISTAL STEMS ACE-FISCHER(R), TEMPFIX(R), HOFFMAN CLASSIC(TM) EXTERNAL FIXATORS DISCOVERY-MOSAIC TOTAL HUMERUS SYSTEM MG II POROUS TOTAL KNEE SYSTEM MAESTRO TOTAL WRIST ULTRA-DRIVE 3 BIOMET MODULAR FEMORAL REVISION SYSTEM 100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAXROM AND +3 HI-WALL Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions, Sterile/Non-Sterile ZPS / Screws and Washers SIRIUS FEMORAL STEM REACH HIP COMPONENT COMPREHENSIVE HUMERAL FRACTURE POSITIONING SLEEVE OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS) TRILOGY LONGEVITY CONSTRAINED LINER Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert Cannulated Bone Screw System, Herbert Mini BIO-MODULAR SHOULDER SYSTEM UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTS ZIMMER PERIARTICULAR LOCKING SYSTEM ZIMMER PLATES AND SCREWS SYSTEM(ZPS)- NON-STERILE PLATES AND SCREWS BIOMET FEMORAL LOCKING NAIL SYSTEM CEMENTED FEMORAL HEAD RESURFING DEVICE COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM (SHORT SPINDLE AND ANCHOR PLUG) COONRAD III TOTAL ELBOW Biomet Proximal Humerus Plating System DISCOVERY ELBOW PROXIMAL TIBIA LOCKING PLATE STANDARD AND LARGE, 3.5MM LOW PROFILE AND MULTIDIRECTIONAL SCREWS Template bit, drill RINGLOC + HYBRID ACETABULAR SYSTEM ZIMMER M/L TAPER HIP PROSTHESIS, 7711 SERIES VERSYS HIP SYSTEM--FIBER METAL TAPER HIP PROSTHESIS Tray, Surgical, Instrument FINN KNEE PROSTHESIS VANGUARD SSK KNEE SYSTEM TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENE BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS Reamer ORTHOPEDIC SALVAGE SYSTEM- OSS PATRIOT PROTRUSIO CAGE guide, surgical, instrument ONCOLOGY SALVAGE SYSTEM EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE BIOMET PHOENIX ANKLE NAIL AND ANKLE ARTHRODESIS NAIL TITANIUM LOW PROFILE SCREWS VANGUARD M SERIES UNICONDYLAR TIBIAL BEARINGS VERSYS HIP SYSTEM BEADED HIP PROSTHESIS HEDROCEL REVISION CUP, MODEL 02-2YY-ZZZZ DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY KNEE PROSTHESES 100KGY E-POLY ACETABULAR LINERS-ADDITIONAL PROFILES punch, femoral neck TA HIP PROSTHESIS Screwdriver RS (REDUCED SIZE) OSS (ORTHOPEDIC SALVAGE SYSTEM) ADDITIONAL COMPONENTS Tap, bone COMPREHENSIVE REVERSE SHOULDER REDUCED SIZE ONCOLOGY SALVAGE SYSTEM JUGGERKNOTLESS SOFT ANCHORS, JUGGERKNOTLESS M SOFT ANCHORS, JUGGERKNOTLESS SOFT ANCHORS WITH NEEDLES, JUGGERKNOTLESS SOF GAMMA SYSTEM COMPRESS ANTI-ROTATION SPINDLES VANGUARD COMPLETE KNEE SYSTEM BIOMET TIBIAL LOCKING NAIL SYSTEM MAXIM ACCEL KNEE SYSTEM COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM INSALL/BURSTEIN(TM)* II TIBIAL WEDGES XR-SERIES BI-METRIC FEMORAL COMPONENTS HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN RH 125 DEGREE 9-13MM AGC TOTAL KNEE PROSTHESIS VANGUARD SSK 360 REVISION KNEE SYSTEM CO-CR ANSWER FEMORAL COMPONENT FIXED BEARING UNI COMPONENT Biomet Knee Joint Replacement Prostheses VANGUARD 360 OSSEOTI TIBIAL SLEEVE AUGMENT DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW UNIVERSAL LOCKING SYSTEM, 2.7MM PLATES & SCREWS LAPIDUS PLATE, 3.5MM INLINE FUSION PLATE, 3.5MM MTP PLATE (LEFT AND RIGHT) G7 ACETABULAR SYSTEM ZMR HIP SYSTEM KWZ-PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER ZIMMER UNIVERSAL LOCKING SYSTEM: 3.5 MM LOCKING PLATES AND SCREWS COBALT-CHROMIUM-MOLYBDENUM (CO-CR-MO) ALLOY FEMORAL HEADS W/CO-NIDIUM SURFACE TREATMENT 3-PIECE PROXIMAL HUMERAL REPLACEMENT SYSTEM COLLARLESS POLISHED TAPER HIP PROSTHESIS G7 Freedom and Offset Liners, Freedom Head, Size 32

    Establishment Types

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