FDA Registration Active 🇨🇷 Costa Rica

Zimmer Biomet Centroamerica SA

Reg #: 3014315560 · FEI: 3014315560 · Expires 2026
Products
25
Proprietary Names
19
Establishment Types
1
Classifications
25

Registration Details

Registration Name
Zimmer Biomet Centroamerica SA
Registration Number
3014315560
FEI Number
3014315560
Status
Active
Expiry Year
2026
Initial Importer
No
Address
Oficentro Ejecutivo La Sabana, Edificio 7, Piso 3
City
san jose
Country
CR

Regulatory Submissions

510(k) Number
K173411
PMA Number
P010014

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
Phone
715 9289253

Products

Device Name Product Code
Prosthesis, Elbow, Constrained, Cemented JDC
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented MBF
Shoulder Prosthesis, Reverse Configuration PHX
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
Screw, Fixation, Bone HWC
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) KWA
Pin, Fixation, Smooth HTY
Pin, Fixation, Threaded JDW
Rod, Fixation, Intramedullary And Accessories HSB
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite LXT
Plate, Fixation, Bone HRS
Washer, Bolt Nut HTN
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
Bone Cement, Antibiotic MBB
Arthroscope HRX
Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing NRA
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
Gown, Surgical FYA
Fastener, Fixation, Nondegradable, Soft Tissue MBI
Screw, Fixation, Intraosseous DZL
Syringe, Irrigating (Non Dental) KYZ
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO

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 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER TOTALSHIELD SURGICAL HELMET SYSTEM BIOMET SPORTS MEDICINE JUGGERKNOT SOFT ANCHOR EBI PERIARTICULAR PLATING SYSTEM JUGGERKNOT MINI SOFT ANCHOR ZINDRICK IM ROD SURGICAL SEALANT APPLICATOR TIP ENDOSCOPIC TIP FINE GRAIN CAST COBALT CHROMIUM HIP STEMS

Establishment Types

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