BIOMET CHILE S.A.

FDA Device Registration & Listing · Santiago de Chile Region Metropolitana, CL · Registration 3014302784

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3014302784
FEI Number
3014302784
Entity Name
BIOMET CHILE S.A.
City/State/Country
Santiago de Chile Region Metropolitana, CL
Establishment Address
Av. Santa Clara No. 085 Floor 7, HUECHURABA, Santiago de Chile Region Metropolitana 8580000, CL
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
ZimmerBiomet Americas DFE (Owner Number: 10056779)
Owner / Operator Contact Address
1800 W Center St., Warsaw, IN 46580, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JDC Prosthesis, Elbow, Constrained, Cemented Orthopedic Class 2 888.3150 2018-02-16
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2018-02-09
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2018-02-09
OQH Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented Orthopedic Class 2 888.3350 2018-02-09
MAY Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish Orthopedic Class 2 888.3353 2018-02-09
PBI Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive Orthopedic Class 2 888.3310 2018-02-09
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2018-02-09
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2018-02-09
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2018-02-09
OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Orthopedic Class 2 888.3353 2018-02-09
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2018-02-09
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2018-02-09
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2018-02-09
JDG Prosthesis, Hip, Femoral Component, Cemented, Metal Orthopedic Class 2 888.3360 2018-02-09
JDC Prosthesis, Elbow, Constrained, Cemented Orthopedic Class 2 888.3150 2018-02-16
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2018-02-19
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2018-02-19
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2018-02-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2018-02-16
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2018-02-08
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2018-02-16
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3670 2018-02-16
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2018-02-16
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2018-02-16
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2018-01-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-01-16
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2018-02-08
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2018-02-08
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2018-02-08
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2018-02-16
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2018-02-16
LOD Bone Cement Orthopedic Class 2 888.3027 2018-02-16
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2018-02-05
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2018-02-05
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2018-02-08
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2018-02-08
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2018-02-19
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2018-02-08
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2018-02-08
MAY Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish Orthopedic Class 2 888.3353 2018-02-08
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2018-02-08
OQH Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented Orthopedic Class 2 888.3350 2018-02-08
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2018-02-08
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2018-02-19
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2018-02-19
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2018-02-16
KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic Class 2 888.3360 2018-02-19
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2018-02-08
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2018-02-08
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2018-02-08
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2018-02-08
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2018-02-08
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2018-02-08
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2018-02-08
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2018-02-08
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2018-02-08
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2018-02-08
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2018-02-16
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2018-02-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2018-02-19
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2018-02-19
MBV Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2018-02-19
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2018-02-19
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2018-02-08
MLR Sterilizer, Chemical General Hospital Class 2 880.6860 2018-02-08
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2018-02-08
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2018-02-08
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2018-02-08
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2018-02-09
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2018-02-08
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2018-02-08
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2018-02-08
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2018-02-08
JDC Prosthesis, Elbow, Constrained, Cemented Orthopedic Class 2 888.3150 2018-02-16
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2018-02-16
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3670 2018-02-16
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2018-02-16
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2018-02-08
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2018-02-08
HWQ Passer Orthopedic Class 1 888.4540 2018-02-06
HWR Driver, Prosthesis Orthopedic Class 1 888.4540 2018-02-06
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2018-02-16
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2018-02-16
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2018-02-16
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3670 2018-02-16
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2018-02-09
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3670 2018-02-16
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2018-02-16
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2018-02-16
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2018-02-16
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2018-02-19
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2018-02-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-02-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2018-02-19
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-02-19
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2018-02-19
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2018-02-19
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2018-02-08
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2018-02-08
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2018-02-19
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2018-02-19
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2018-02-19
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2018-02-19
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2018-02-19
JWJ Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained Orthopedic Class 2 888.3800 2018-02-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-02-05
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2018-02-19
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2018-02-19
HWD Starter, Bone Screw Orthopedic Class 1 888.4540 2018-02-28
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2018-02-08
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2018-01-16
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2018-02-19
MBV Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2018-02-19
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2018-02-08
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2018-02-08
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2018-02-08
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2018-02-08
LZY Prosthesis, Hip, Hemi-, Femoral, Metal Ball Orthopedic Class 2 888.3360 2018-02-08
KWB Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal Orthopedic Class 3 888.3370 2018-02-08
JDL Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) Orthopedic Class 3 888.3320 2018-02-08
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2018-02-08
KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) Orthopedic Class 3 888.3330 2018-02-08
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Orthopedic Class 2 888.3358 2018-02-08
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2018-02-08
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2018-02-09
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2018-02-09
KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) Orthopedic Class 3 888.3330 2018-02-09
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2018-02-09
MAY Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish Orthopedic Class 2 888.3353 2018-02-09
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2018-02-09
JDL Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) Orthopedic Class 3 888.3320 2018-02-09
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2018-02-09
JDL Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) Orthopedic Class 3 888.3320 2018-02-09
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2018-02-09
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2018-02-09
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2018-02-09
MAY Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish Orthopedic Class 2 888.3353 2018-02-09
KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) Orthopedic Class 3 888.3330 2018-02-09
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2018-02-09
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2018-02-09
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2018-02-09
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2018-02-19
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2018-02-19
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2018-02-16
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2018-02-19
JWJ Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained Orthopedic Class 2 888.3800 2018-02-08
JDX Instrument, Surgical, Sonic And Accessory/Attachment Orthopedic Class 2 888.4580 2018-02-09
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2018-02-09
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2018-02-09
KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) Orthopedic Class 3 888.3330 2018-02-09
MAY Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish Orthopedic Class 2 888.3353 2018-02-09
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2018-02-09
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2018-02-09
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2018-02-09
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2018-02-09
JDL Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) Orthopedic Class 3 888.3320 2018-02-09
MAY Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish Orthopedic Class 2 888.3353 2018-02-08
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2018-02-08
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2018-02-08
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2018-02-08
OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Orthopedic Class 2 888.3353 2018-02-08
OQH Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented Orthopedic Class 2 888.3350 2018-02-08
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2018-02-08
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2018-02-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-02-19
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2018-02-19
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2018-02-19
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2018-02-19
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2018-02-19
OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Orthopedic Class 2 888.3353 2018-02-19
OQH Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented Orthopedic Class 2 888.3350 2018-02-19
LZY Prosthesis, Hip, Hemi-, Femoral, Metal Ball Orthopedic Class 2 888.3360 2018-02-19
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2018-02-19
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2018-02-19
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2018-02-19
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2018-02-19
JDG Prosthesis, Hip, Femoral Component, Cemented, Metal Orthopedic Class 2 888.3360 2018-02-19
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2018-02-19
KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic Class 2 888.3360 2018-02-19
PBI Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive Orthopedic Class 2 888.3310 2018-02-19
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2018-02-14
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2018-02-14
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2018-02-16
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2018-02-16
HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3530 2018-02-19
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2018-02-19
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-02-19
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2018-02-14
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3670 2018-02-14
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2018-02-14
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2018-02-14
KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3540 2018-03-28
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2018-01-16
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2018-01-16
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2018-01-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-01-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2018-02-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-02-08
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2018-02-19
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-02-19
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2018-02-19
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2018-02-19
KXA Prosthesis, Hip, Femoral, Resurfacing Orthopedic Class 2 888.3400 2018-02-08
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2018-02-14
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2018-02-14
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2018-02-14
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2018-02-14
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2018-02-14
JDL Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) Orthopedic Class 3 888.3320 2018-02-14
KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) Orthopedic Class 3 888.3330 2018-02-14
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2018-02-14
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2018-02-14
JDC Prosthesis, Elbow, Constrained, Cemented Orthopedic Class 2 888.3150 2018-02-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2018-02-19
JDC Prosthesis, Elbow, Constrained, Cemented Orthopedic Class 2 888.3150 2018-02-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-02-19
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2018-02-19
HWT Template Orthopedic Class 1 888.4800 2018-02-14
HTW Bit, Drill Orthopedic Class 1 888.4540 2018-02-06
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2018-02-08
KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) Orthopedic Class 3 888.3330 2018-02-08
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2018-02-08
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2018-02-08
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2018-02-08
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2018-02-28
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2018-02-19
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2018-02-19
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2018-02-08
KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) Orthopedic Class 3 888.3330 2018-02-08
HTO Reamer Orthopedic Class 1 888.4540 2018-02-28
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2018-02-19
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2018-02-19
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2018-02-14
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2018-02-06
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2018-02-19
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2018-02-19
KWI Prosthesis, Elbow, Hemi-, Radial, Polymer Orthopedic Class 2 888.3170 2018-02-16
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2018-02-19
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2018-02-16
HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3530 2018-02-19
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2018-02-08
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2018-02-08
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2018-02-08
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2018-02-08
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2018-02-19
MAY Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish Orthopedic Class 2 888.3353 2018-02-08
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2018-02-08
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2018-02-08
OQH Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented Orthopedic Class 2 888.3350 2018-02-08
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2018-02-08
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2018-02-08
HWP Punch, Femoral Neck Orthopedic Class 1 888.4540 2018-02-06

Official Correspondent

No official correspondent registered.

US Agent Details

Stephanie Lynch Business: Zimmer Biomet Email: stephanie.lynch@zimmerbiomet.com Phone: (715) 9289253

Related Public Records

Same Entity

ZimmerBiomet Americas DFE
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3006809628 Biomet Mexico Mexico City Ciudad de Mexico, MX
3014315560 Zimmer Biomet Centroamerica SA san jose, CR
3013086329 WM WORLD MEDICAL IMPORTACAO E EXPORTACAO LTDA. Rio de Janeiro, BR

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K983036 Biomet, Inc. SINGLE AXLE TOTAL ELBOW 1999-04-30
K040389 Zimmer, Inc. COONRAD/MORREY ELBOW CEMENT RESTRICTOR 2004-05-17
K940328 Orthopaedic Innovations, Inc. PRIME CEMENTED HIP SYSTEM 1995-04-07
K950761 Biomet, Inc. INDEX ACETABULAT COMPONENT 1995-05-02
K972928 Howmedica, Inc. KERBOULL CROSS 1997-11-03

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0032-2009 Biomet, Inc. 2
Biomet brand Discovery Elbow, 3 mm x 75 mm right ulna with bearing/bond coat, TI 6AL 4V Alloy/ARCOM UHMWPE, For cemented use only, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 114813. The product intended use is for Orthopedic implant.
Z-0033-2009 Biomet, Inc. 2
Biomet brand Discovery Elbow, 3 mm x 115 mm right ulna with bearing/bond coat, TI 6AL 4V Alloy/ARCOM UHMWPE, For cemented use only, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 114817. The product intended use is for Orthopedic implant.
Z-0007-2023 Zimmer, Inc. 2
G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip arthroplasty
Z-0034-2022 Flower Orthopedics Corporation 2
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Z-0012-2019 Exactech, Inc. 2
Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014302784. Last updated year: 2026. Please use registration number 3014302784 when referencing this establishment in official correspondence.
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