FDA Registration Active 🇦🇺 Australia

Taper 2™ Porous Femoral Stem

Reg #: 3035366890 · FEI: 3035366890 · Expires 2025
Products
11
Proprietary Names
1
Establishment Types
1
Classifications
11

Registration Details

Registration Name
Zimmer Biomet Pty Ltd
Registration Number
3035366890
FEI Number
3035366890
Status
Active
Expiry Year
2025
Initial Importer
No
Address
Level 4, 12 Narabang Way, Belrose, NSW
City
Sydney New South Wales
Country
AU

Regulatory Submissions

510(k) Number
K050441

Owner / Operator

Firm Name
Zimmer Biomet APAC DFE
Operator Number
10056128
Address
Zimmer Biomet Shanghai
City
Shanghai
State
CN-SH
Postal Code
200051
Country
CN

Products

Device Name Product Code
Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) JDL
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) KWA
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous MBL
Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal KWB
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
Prosthesis, Hip, Hemi-, Femoral, Metal Ball LZY
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH

Proprietary Names

Taper 2™ Porous Femoral Stem

Establishment Types

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