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
- [email protected]
- Phone
- 715 9289253
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Elbow, Constrained, Cemented | JDC | Class 2 | Orthopedic | No | 2020-09-14 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2020-09-14 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | MBF | Class 2 | Orthopedic | No | 2020-09-14 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2020-09-14 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2020-09-14 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2018-01-24 |
| Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | KWA | Class 3 | Orthopedic | No | 2018-01-24 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2018-01-24 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2018-01-24 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2018-01-24 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2018-01-24 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | LXT | Class 2 | Orthopedic | No | 2018-01-24 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2018-01-24 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2018-01-24 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2020-09-14 |
| Bone Cement, Antibiotic | MBB | Class 2 | Orthopedic | No | 2020-09-14 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2018-01-24 |
| Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing | NRA | Class 3 | Unknown | No | 2019-08-28 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2019-08-28 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2020-01-16 |
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2020-09-25 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2018-01-24 |
| Screw, Fixation, Intraosseous | DZL | Class 2 | Dental | No | 2020-09-14 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2019-08-28 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2018-01-24 |
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