FDA Registration Active 🇲🇽 Mexico

Biomet Mexico

Reg #: 3006809628 · FEI: 3006809628 · Expires 2026
Products
15
Proprietary Names
8
Establishment Types
1
Classifications
15

Registration Details

Registration Name
Biomet Mexico
Registration Number
3006809628
FEI Number
3006809628
Status
Active
Expiry Year
2026
Initial Importer
No
Address
Torre Jade Av. Periferico Sur No. 4829, 401. Col Parques del Pedregal,
City
Mexico City Ciudad de Mexico
Country
MX

Regulatory Submissions

510(k) Number
K101086

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, Hip, Hemi-, Femoral, Metal KWL
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) JDL
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish MAY
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) KWA
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQG
Orthopedic Manual Surgical Instrument LXH
Fastener, Fixation, Nondegradable, Soft Tissue MBI
Extractor HWB

Proprietary Names

TAPERLOC COMPLETE TAPERLOC COMPLETE MICROPLASTY STEM orthopedic manual surgical instrument FEMORAL HOOK Extractor TAPERLOC COMPLETE SIZE 4MM AND XR 123 TAPERLOC COMPLETE, SIZE 5 AND 6 MALLORY/HEAD TOTAL HIP SYSTEM; HA MALLORY/HEAD TOTAL HIP SYSTEM; BI-METRIC FEMORAL COMPONENTS

Establishment Types

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