Zimmer Biomet Centroamerica SA

FDA Device Registration & Listing · san jose, CR · Registration 3014315560

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
3014315560
FEI Number
3014315560
Entity Name
Zimmer Biomet Centroamerica SA
City/State/Country
san jose, CR
Establishment Address
Oficentro Ejecutivo La Sabana, Edificio 7, Piso 3, san jose 10101, CR
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
K061098
PMA Number
N/A

All Registered Proprietary Names

Comprehensive Segmental Revision System (SRS) ACE 3.5MM CORTICAL BONE SCREW M2A MAGNUM SYSTEM TRAUMA INTERNAL FIXATION SYSTEMS EBI TROCHANTERIC NAIL SYSTEM StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis BIODRIVE CANNULATED SCREW SYSTEM INTEGRATED ENDOSCOPY SYSTEM 1000 Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing MALLORY/HEAD CALCAR REPLACEMENT WITH INTERLOCKING SLOTS BI-METRIC POROUS COLLARED STEM WITH INTERLOCKING SLOTS EBI OPTILOCK PERIARTICULAR PLATING SYSTEM

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 2020-09-14
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2020-09-14
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3670 2020-09-14
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2020-09-14
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2020-09-14
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-01-24
KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) Orthopedic Class 3 888.3330 2018-01-24
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2018-01-24
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2018-01-24
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2018-01-24
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2018-01-24
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-01-24
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2018-01-24
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2018-01-24
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2018-01-24
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2018-01-24
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2020-09-14
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2020-09-14
MBB Bone Cement, Antibiotic Orthopedic Class 2 888.3027 2020-09-14
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-01-24
HRX Arthroscope Orthopedic Class 2 888.1100 2018-01-24
NRA Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing Unknown Class 3 N/A 2019-08-28
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2019-08-28
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2018-01-22
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-01-22

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
3013086329 WM WORLD MEDICAL IMPORTACAO E EXPORTACAO LTDA. Rio de Janeiro, BR
3014302784 BIOMET CHILE S.A. Santiago de Chile Region Metropolitana, CL

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
K141345 Tornier S.A.S. AEQUALIS FX2 2014-11-18
K904879 Endotec, Inc. BEUCHEL-PAPPAS GLENOID COMPONENT 1991-01-28
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08

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-0012-2019 Exactech, Inc. 2
Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery
Z-0023-06 Zimmer Inc. 2
Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604000.
Z-0024-06 Zimmer Inc. 2
Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604046.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014315560. Last updated year: 2026. Please use registration number 3014315560 when referencing this establishment in official correspondence.
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