Device
SMR Shoulder - TT HYBRID Glenoid BASEPLATE LARGE LOW - PEG L
Manufacturer
LIMACORPORATE SPA
LIMACORPORATE SPA
Model: 1379.5G.320
Catalog: 1379.5G.320
DI: 08033390216067
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-11
Current Version: 2026-05-19
Description
SMR Shoulder - TT HYBRID Glenoid BASEPLATE LARGE LOW - PEG L
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
4d2d2aac-873e-48ee-a7d4-cd96c2c56769
Distribution Status:
In Commercial Distribution
DUNS Number:
432066322
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:
08033390216067
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 36259
Name: Shoulder glenoid fossa prosthesis, prefabricated
Definition:
An implantable, prefabricated component of a total shoulder prosthesis (glenoid component) designed to replace or repair the glenoid fossa; it is not a custom-made device. It is cup-like in shape and typically made of polyethylene (PE), but may be made of metal or a combination of PE and metal; it may include fixation devices (e.g., screws) for attachment to the scapula.
FDA Product Codes
KWT
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
PHX
Shoulder Prosthesis, Reverse Configuration
MBF
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
KWS
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Premarket Submissions
Submission Number:
K213785
Supplement Number:
000
Device Sizes
Device Size - Size Text:
LARGE LOW - PEG L
Device Size - Size Type:
Device Size Text, specify