FDA UDI In Commercial Distribution 🇺🇸 United States

FIXA Ti-Por®

DI: 08050507130061 · Model: Acetabular Shell · ADLER ORTHO SPA
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
FIXA Ti-Por®
Primary DI
08050507130061
Version / Model
Acetabular Shell
Catalog Number
0793456
Company Name
ADLER ORTHO SPA
Labeler DUNS
338847291
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-03-03
Public Version
1
Public Version Date
2025-03-11
Public Version Status
New
Public Device Record Key
4575e8b8-278a-4090-aacc-df8373eb30bf

Device Description

FIXA Ti-Por® CUP Size 56 Group C

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous

GMDN Terms

Code Name
43167 Acetabular shell

Identifiers

Type ID
Primary 08050507130061

Device Sizes

Type Value Unit Text
Device Size Text, specify Size 56 Group C