Shoulder Innovations TSA 2N1HS00040

GUDID B1132N1HS000400

Shoulder Innovations - Flat Humeral Sizer, Size 40mm

Shoulder Innovations, Inc.

Orthopaedic prosthesis implantation positioning instrument, reusable
Primary Device IDB1132N1HS000400
NIH Device Record Keybddbf150-b90a-46ff-8075-472f286bac9e
Commercial Distribution StatusIn Commercial Distribution
Brand NameShoulder Innovations TSA
Version Model NumberFlat Humeral Sizer, Size 40mm
Catalog Number2N1HS00040
Company DUNS080404519
Company NameShoulder Innovations, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone616-294-1026
Emailinfo@shoulderinnovations.com
Phone616-294-1026
Emailinfo@shoulderinnovations.com
Phone616-294-1026
Emailinfo@shoulderinnovations.com
Phone616-294-1026
Emailinfo@shoulderinnovations.com
Phone616-294-1026
Emailinfo@shoulderinnovations.com
Phone616-294-1026
Emailinfo@shoulderinnovations.com
Phone616-294-1026
Emailinfo@shoulderinnovations.com
Phone616-294-1026
Emailinfo@shoulderinnovations.com
Phone616-294-1026
Emailinfo@shoulderinnovations.com
Phone616-294-1026
Emailinfo@shoulderinnovations.com
Phone616-294-1026
Emailinfo@shoulderinnovations.com
Phone616-294-1026
Emailinfo@shoulderinnovations.com
Phone616-294-1026
Emailinfo@shoulderinnovations.com
Phone616-294-1026
Emailinfo@shoulderinnovations.com
Phone616-294-1026
Emailinfo@shoulderinnovations.com
Phone616-294-1026
Emailinfo@shoulderinnovations.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB1132N1HS000400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B1132N1HS000400]

Moist Heat or Steam Sterilization


[B1132N1HS000400]

Moist Heat or Steam Sterilization


[B1132N1HS000400]

Moist Heat or Steam Sterilization


[B1132N1HS000400]

Moist Heat or Steam Sterilization


[B1132N1HS000400]

Moist Heat or Steam Sterilization


[B1132N1HS000400]

Moist Heat or Steam Sterilization


[B1132N1HS000400]

Moist Heat or Steam Sterilization


[B1132N1HS000400]

Moist Heat or Steam Sterilization


[B1132N1HS000400]

Moist Heat or Steam Sterilization


[B1132N1HS000400]

Moist Heat or Steam Sterilization


[B1132N1HS000400]

Moist Heat or Steam Sterilization


[B1132N1HS000400]

Moist Heat or Steam Sterilization


[B1132N1HS000400]

Moist Heat or Steam Sterilization


[B1132N1HS000400]

Moist Heat or Steam Sterilization


[B1132N1HS000400]

Moist Heat or Steam Sterilization


[B1132N1HS000400]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-28
Device Publish Date2025-04-18

On-Brand Devices [Shoulder Innovations TSA]

B1132N1KS000010Steripack Surgical Utility Case
B1132N2AI200100Shoulder Innovations InSet Plus Glenoid Implant, Circular In Line Peg, 20mm x 10°, UHMWPE
B1132N2AI200050Shoulder Innovations InSet Plus Glenoid Implant, Circular In Line Peg, 20mm x 5°, UHMWPE
B1130S0CI200080Shoulder Innovations - TSA. Glenoid Circular In Line Peg. 20m x 8mm. UHMWPE.
B1130S0CI200060Shoulder Innovations - TSA. Glenoid Circular In Line Peg. 20m x 6mm. UHMWPE.
B1132N1KS000150Steripack Surgical Utility Case Generic
B1132N2AI330100Shoulder Innovations InSet Plus Glenoid Implant, Circular In Line Peg, 33mm x 10°, UHMWPE
B1132N2AI330050Shoulder Innovations InSet Plus Glenoid Implant, Circular In Line Peg, 33mm x 5°, UHMWPE
B1132N1AI330100Shoulder Innovations InSet Plus Glenoid Trial, Circular In Line Peg, 33mm x 10°, Stainless Stee
B1132N1AI330050Shoulder Innovations InSet Plus Glenoid Trial, Circular In Line Peg, 33mm x 5°, Stainless Steel
B1132N1AC330100Shoulder Innovations InSet Plus Glenoid Trial, Circular Center Peg, 33mm x 10°, Stainless Steel
B1132N1AC330050Shoulder Innovations InSet Plus Glenoid Trial, Circular Center Peg, 33mm x 5°, Stainless Steel
B1130S0CI330080Shoulder Innovations - TSA. Glenoid Circular In Line Peg. 33 mm x 8 mm. UHMWPE.
B1130S0CI330060Shoulder Innovations - TSA. Glenoid Circular In Line Peg. 33mm x 6mm. UHMWPE.
B1132N1HS000520Shoulder Innovations - Flat Humeral Sizer, 52mm
B1132N1HS000460Shoulder Innovations - Flat Humeral Sizer, Size 46mm
B1132N1HS000400Shoulder Innovations - Flat Humeral Sizer, Size 40mm

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.