Shoulder Innovations TSA

FDA UDI

Class II (US FDA UDI)

by SHOULDER INNOVATIONS, Inc

Identity

Trade Name: Shoulder Innovations TSA FDA UDI
Generic Name: Total shoulder prosthesis FDA UDI
Device Name: Shoulder Innovations InSet Plus Glenoid Trial, Circular In Line Peg, 24mm x 10°, Stainless Steel FDA UDI
Model / Reference: 24 mm x 10° FDA UDI
Description: Shoulder Innovations InSet Plus Glenoid Trial, Circular In Line Peg, 24mm x 10°, Stainless Steel FDA UDI

Identifiers

Catalog Number: 2N1AI24010 FDA UDI
Primary DI / UDI-DI: B1132N1AI240100 FDA UDI
510(k) Number: K102670 FDA UDI
K110905 FDA UDI
K111596 FDA UDI
FDA Product Code: HSD FDA UDI
KWS FDA UDI
KWT FDA UDI
GMDN Term: Total shoulder prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3690 FDA UDI
888.3660 FDA UDI
888.3650 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

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Category: Total shoulder prosthesis Shoulder glenoid fossa prosthesis, prefabricated

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Cleared under the same submission

K102670 also covers:

K110905 also covers:

K111596 also covers:

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 1b26691e-237e-4750-bf69-ebcbb4933816 36 fields · synced Jul 28, 2026

Shoulder Innovations TSA

Identity

Identifiers

Classification

Clinical & Handling

Similar devices

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

Manufacturer

Sources (1)