← Back to catalogue

Shoulder Innovations Tsa System

FDA UDI

Class II (US FDA UDI)

by SHOULDER INNOVATIONS, Inc

Identity

Trade Name
SHOULDER INNOVATIONS TSA SYSTEM FDA UDI
Generic Name
Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Device Name
Glenoid Reamer Assembly - 20MM FDA UDI
Model / Reference
Glenoid Reamer Assembly - 20MM FDA UDI
Description
Glenoid Reamer Assembly - 20MM FDA UDI

Identifiers

Catalog Number
0S1GR20075 FDA UDI
Primary DI / UDI-DI
B1130S1GR200750 FDA UDI
FDA Product Code
KWT FDA UDI
KWS FDA UDI
HSD FDA UDI
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI

Classification

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

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic prosthesis implantation positioning instrument, reusable

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

Similar devices

Also classified as Orthopaedic prosthesis implantation positioning instrument, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
SHOULDER INNOVATIONS, Inc

Sources (1)

  • FDA UDI 146fb2b2-5777-4f34-8fe5-94a9ef8277d4 35 fields · synced Jun 1, 2026