Device
Trial - Humeral Poly - Standard, +3 lateralization, 42 mm sphere
Manufacturer
Restor3d, Inc.
Restor3d, Inc.
Model: 5500-H42U3
DI: 00840097535999
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-14
Current Version: 2026-05-22
Description
Trial - Humeral Poly - Standard, +3 lateralization, 42 mm sphere
Sterilization
Method Types - Sterilization Method:
Moist Heat or Steam Sterilization
Device Sterile:
No
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
6c02b8cf-f534-4c29-bd93-c746e1ba6d63
Distribution Status:
In Commercial Distribution
DUNS Number:
080819836
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00840097535999
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 60937
Name: Reverse shoulder cup prosthesis trial, reusable
Definition:
A copy of a final reverse shoulder prosthesis cup designed to be used before primary or revision implant surgery to validate the proper size of the permanent prosthesis required by the patient and to ensure its proper orientation and positioning. It is intended to connect to a reverse shoulder prosthesis/trial prosthesis body and articulates with a reverse shoulder prosthesis/trial prosthesis head; it is typically made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use.
FDA Product Codes
PHX
Shoulder Prosthesis, Reverse Configuration
Premarket Submissions
Submission Number:
K243643
Supplement Number:
000