Device
Initia Acetabular Offset Hooded Liner, E-CIMA 28-60/62/64
Manufacturer
KYOCERA MEDICAL TECHNOLOGIES, INC.
KYOCERA MEDICAL TECHNOLOGIES, INC.
Model: Initia T3
Catalog: 1535-428-603
DI: 00841523167982
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-24
Current Version: 2026-05-04
Description
Initia Acetabular Offset Hooded Liner, E-CIMA 28-60/62/64
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
963f5cee-9584-40ba-ad9f-853de7f942fc
Distribution Status:
In Commercial Distribution
DUNS Number:
116995646
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00841523167982
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 43167
Name: Acetabular shell
Definition:
An implantable component of a two-piece acetabulum prosthesis that forms the outer portion of the prosthesis, fixed to the pelvis to provide a base for the inner portion (acetabular liner). It is made of metal, and is fixed with bone cement and/or fixation devices.
FDA Product Codes
LPH
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
LZO
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Premarket Submissions
Submission Number:
K242045
Supplement Number:
000