FDA Registration Active 🇳🇱 Netherlands

44MM E1 ACETABULAR LINER WITH 44MM BIOLOX DELTA OPTION CERAMIC HEAD OR 44MM M A MAGNUM

Reg #: 3013055499 · FEI: 3013055499 · Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5

Registration Details

Registration Name
Biomet Global Supply Chain Center B.V.
Registration Number
3013055499
FEI Number
3013055499
Status
Active
Expiry Year
2025
Initial Importer
No
Address
4836 LD Breda
City
Hazeldonk Noord-Brabant
Country
NL

Regulatory Submissions

510(k) Number
K093549

Owner / Operator

Firm Name
ZIMMER GMBH
Operator Number
9064978
Address
Zahlerweg 4
City
Zug
State
CH-ZG
Postal Code
6300
Country
CH

US Agent

Business Name
Zimmer Biomet
Contact Name
Holly Seppanen
Address
1800 West Center Street
City
Warsaw
State
IN
ZIP
46580
Country
US
Phone
952 8470494

Products

Device Name Product Code
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish MAY
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO

Proprietary Names

44MM E1 ACETABULAR LINER WITH 44MM BIOLOX DELTA OPTION CERAMIC HEAD OR 44MM M A MAGNUM

Establishment Types

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