Device
Shoulder Innovations - TSA - Humeral Stemless System. Instrument. Standard Size Stemless Broach
Manufacturer
Shoulder Innovations, Inc.
Shoulder Innovations, Inc.
Model: Stemless Broach - Standard
Catalog: 2G1HB30002
DI: B1132G1HB300020
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-04
Current Version: 2026-05-12
Description
Shoulder Innovations - TSA - Humeral Stemless System. Instrument. Standard Size Stemless Broach
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:
82ba174b-54f1-4329-aa51-3c3ffeb94098
Distribution Status:
In Commercial Distribution
DUNS Number:
080404519
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:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
B1132G1HB300020
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code:
Name:
FDA Product Codes
MBF
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
HSD
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
KWT
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
KWS
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
PKC
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained