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Shoulder Innovations InSet Humeral Stemless

FDA UDI

Class II (US FDA UDI)

by SHOULDER INNOVATIONS, Inc

Identity

Trade Name
Shoulder Innovations InSet Humeral Stemless FDA UDI
Generic Name
Total shoulder prosthesis FDA UDI
Device Name
Shoulder Innovations - TSA - InSet Humeral Stemless - 28mm | Size 0 FDA UDI
Model / Reference
28mm | Size 0 FDA UDI
Description
Shoulder Innovations - TSA - InSet Humeral Stemless - 28mm | Size 0 FDA UDI

Identifiers

Catalog Number
2G2SC21280 FDA UDI
Primary DI / UDI-DI
B1132G2SC212800 FDA UDI
FDA Product Code
MBF FDA UDI
HSD FDA UDI
KWT FDA UDI
KWS FDA UDI
PKC FDA UDI
GMDN Term
Total shoulder prosthesis 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI

Category: Total shoulder prosthesisPress-fit shoulder humeral stem prosthesis

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

Similar devices

Also classified as Press-fit shoulder humeral stem prosthesis.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
SHOULDER INNOVATIONS, Inc

Sources (1)

  • FDA UDI 9a3811cd-4c4c-4d7f-b34d-3c09e67561c1 35 fields · synced May 30, 2026