SHOULDER INNOVATIONS TSA SYSTEM 2N1AB00002

GUDID B1132N1AB000020

Instrument Case Base, Shoulder Innovations Anatomic Glenoid case base

Shoulder Innovations, Inc.

Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable
Primary Device IDB1132N1AB000020
NIH Device Record Key986332f9-66ef-48e3-8aec-c2ec5053f529
Commercial Distribution StatusIn Commercial Distribution
Brand NameSHOULDER INNOVATIONS TSA SYSTEM
Version Model NumberAnatomic Glenoid Case Base
Catalog Number2N1AB00002
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
Emailmatt@shoulderinnovations.com
Phone616 294-1026
Emailmatt@shoulderinnovations.com
Phone616 294-1026
Emailmatt@shoulderinnovations.com
Phone616 294-1026
Emailmatt@shoulderinnovations.com
Phone616 294-1026
Emailmatt@shoulderinnovations.com
Phone616 294-1026
Emailmatt@shoulderinnovations.com
Phone616 294-1026
Emailmatt@shoulderinnovations.com
Phone616 294-1026
Emailmatt@shoulderinnovations.com
Phone616 294-1026
Emailmatt@shoulderinnovations.com
Phone616 294-1026
Emailmatt@shoulderinnovations.com
Phone616 294-1026
Emailmatt@shoulderinnovations.com
Phone616 294-1026
Emailmatt@shoulderinnovations.com
Phone616 294-1026
Emailmatt@shoulderinnovations.com
Phone616 294-1026
Emailmatt@shoulderinnovations.com
Phone616 294-1026
Emailmatt@shoulderinnovations.com
Phone616 294-1026
Emailmatt@shoulderinnovations.com
Phone616 294-1026
Emailmatt@shoulderinnovations.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB1132N1AB000020 [Primary]

FDA Product Code

KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B1132N1AB000020]

Moist Heat or Steam Sterilization

[B1132N1AB000020]

Moist Heat or Steam Sterilization

[B1132N1AB000020]

Moist Heat or Steam Sterilization

[B1132N1AB000020]

Moist Heat or Steam Sterilization

[B1132N1AB000020]

Moist Heat or Steam Sterilization

[B1132N1AB000020]

Moist Heat or Steam Sterilization

[B1132N1AB000020]

Moist Heat or Steam Sterilization

[B1132N1AB000020]

Moist Heat or Steam Sterilization

[B1132N1AB000020]

Moist Heat or Steam Sterilization

[B1132N1AB000020]

Moist Heat or Steam Sterilization

[B1132N1AB000020]

Moist Heat or Steam Sterilization

[B1132N1AB000020]

Moist Heat or Steam Sterilization

[B1132N1AB000020]

Moist Heat or Steam Sterilization

[B1132N1AB000020]

Moist Heat or Steam Sterilization

[B1132N1AB000020]

Moist Heat or Steam Sterilization

[B1132N1AB000020]

Moist Heat or Steam Sterilization

[B1132N1AB000020]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-09
Device Publish Date2023-09-29

On-Brand Devices [SHOULDER INNOVATIONS TSA SYSTEM]

B1130S1GR200650TSA - REAMER/DRILL 20MM
B1132N1AC200100TSA - AUGMENTED GLENOID TRIAL 20MM X 10°
B1132N1AC200050TSA - AUGMENTED GLENOID TRIAL 20MM X 5°
B1130S1SI200080TSA - GLENOID TRIAL 20MM X 8MM
B1130S1SI200060TSA - GLENOID TRIAL 20MM X 6MM
B1130S1GG000200TSA - Peripheral Drill Guide 20mm
B1130S1GR300750Glenoid Reamer Assembly - 30MM
B1130S1GR270750Glenoid Reamer Assembly - 27MM
B1130S1GR240750Glenoid Reamer Assembly - 24MM
B1130S1GR220750Glenoid Reamer Assembly - 22MM
B1130S1GR200750Glenoid Reamer Assembly - 20MM
B1130S1GSP24750SP Glenoid Reamer Assembly - 24MM
B1130S1GSP10010SP 1mm Reamer Stop
B1130S1GSP00050SP Peripheral Drill 5mm
B1130S1GSP00010SP Cannulated Central Drill 6.5mm
B1132N1AB000020Instrument Case Base, Shoulder Innovations Anatomic Glenoid case base
B1132N1AT000030Instrument Case, Shoulder Innovations Humeral Tray
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.