Device
INHANCE SHOULDER SYSTEM REVERSE 145 LINER X-LINKED VITAMIN E PE Ø36+4mm
Manufacturer
DEPUY (IRELAND)
DEPUY (IRELAND)
Model: 550036040
Catalog: 550036040
DI: 10603295563969
Status: New
MRI: MR Conditional
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-01
Current Version: 2026-05-11
Description
INHANCE SHOULDER SYSTEM REVERSE 145 LINER X-LINKED VITAMIN E PE Ø36+4mm
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
5065e993-99aa-4e18-996c-e1aefcbe9767
Distribution Status:
In Commercial Distribution
DUNS Number:
989365556
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:
10603295563969
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 60511
Name: Reverse shoulder prosthesis body
Definition:
A sterile component of a reverse shoulder prosthesis that consists of a metallic piece [e.g., cobalt-chrome-molybdenum (Co-Cr-Mo)], which may be coated [e.g., with hydroxyapatite (HA)], intended to form a connection between a humeral stem prosthesis and a reverse shoulder prosthesis cup.
FDA Product Codes
MBF
PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
PHX
shoulder prosthesis, reverse configuration
KWT
PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
KWS
PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
PAO
prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented
Premarket Submissions
Submission Number:
K253624
Supplement Number:
000