FDA Registration Active 🇦🇺 Australia

Taperloc Complete Size 4mm and XR 123

Reg #: 3035366890 · FEI: 3035366890 · Expires 2025
Products
8
Proprietary Names
1
Establishment Types
1
Classifications
8

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
K120030

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, Hemi-, Femoral, Metal KWL
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQG
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ

Proprietary Names

Taperloc Complete Size 4mm and XR 123

Establishment Types

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