Model: 25864005
DI: 04048844111267
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-06
Current Version: 2026-05-14
Description
ic head taper 12 / 14 mm BIOLOX® delta
Sterilization
Method Types - Sterilization Method:
Radiation Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
7f0ac98e-26db-4cdb-9bc5-d1f1d5b2e1c4
Distribution Status:
In Commercial Distribution
DUNS Number:
324369826
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:
04048844111267
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 38156
Name: Ceramic femoral head prosthesis
Definition:
An implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of ceramic (e.g., alumina, zirconia). It is designed to be attached to the trunnion of a prosthetic femoral stem/shaft or a head/stem adaptor, and to articulate with an acetabulum prosthesis as part of a total hip arthroplasty (THA) or with a bipolar component as part of a partial hip replacement. The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes.
FDA Product Codes
OQI
Hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented
Device Sizes
Device Size - Size Text:
Ø 40 mm / sz. M
Device Size - Size Type:
Device Size Text, specify