Shoulder Innovations Humeral Stemless System

FDA UDI

Class II (US FDA UDI)

by SHOULDER INNOVATIONS, Inc

Identity

Trade Name: Shoulder Innovations Humeral Stemless System FDA UDI
Generic Name: Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Device Name: Shoulder Innovations - TSA - Humeral Stemless System. Instrument. 28mm Stemless Broach FDA UDI
Model / Reference: Stemless Broach - 28mm FDA UDI
Description: Shoulder Innovations - TSA - Humeral Stemless System. Instrument. 28mm Stemless Broach FDA UDI

Identifiers

Catalog Number: 2G1IB21280 FDA UDI
Primary DI / UDI-DI: B1132G1IB212800 FDA UDI
FDA Product Code: MBF FDA UDI
HSD FDA UDI
KWT FDA UDI
KWS FDA UDI
PKC FDA UDI
GMDN Term: Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3670 FDA UDI
888.3690 FDA UDI
888.3650 FDA UDI
888.3660 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

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Expiration Date

FDA UDI

Manufacturing Date

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic prosthesis implantation positioning instrument, reusable Total shoulder prosthesis Press-fit shoulder humeral stem prosthesis

Shoulder Innovations Humeral Stemless System by SHOULDER INNOVATIONS, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: SHOULDER INNOVATIONS, Inc

Sources (1)

FDA UDI 763b8407-a30e-4a3b-87bf-5389fd176aaf 35 fields · synced Jun 1, 2026