Shoulder Innovations Inset Reverse Total Shoulder

FDA UDI

Class I (US FDA UDI)

by SHOULDER INNOVATIONS, Inc

Identity

Trade Name: Shoulder Innovations Inset Reverse Total Shoulder FDA UDI
Generic Name: Total shoulder prosthesis FDA UDI
Device Name: Shoulder Innovations Inset Reverse Total Shoulder - RSA Glenosphere Insertion Guidewire FDA UDI
Model / Reference: RSA Glenosphere Insertion Guidewire FDA UDI
Description: Shoulder Innovations Inset Reverse Total Shoulder - RSA Glenosphere Insertion Guidewire FDA UDI

Identifiers

Catalog Number: 2R2GK00000 FDA UDI
Primary DI / UDI-DI: B1132R2GK000000 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Total shoulder prosthesis FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic prosthesis implantation positioning instrument, reusable Total reverse shoulder prosthesis Total shoulder prosthesis

Shoulder Innovations Inset Reverse Total Shoulder by SHOULDER INNOVATIONS, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Total shoulder prosthesis.

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DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
Arthrex® — Arthrex, Inc. · Class II
DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
PROMOS — Smith & Nephew, Inc. · Class II

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 I	Pending data

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Manufacturer

Manufacturer: SHOULDER INNOVATIONS, Inc

Sources (1)

FDA UDI 56872894-a884-4569-98ad-0c25d0b392e8 35 fields · synced Jun 8, 2026