Tornier Perform® Reversed Augmented Glenoid DWJ502

GUDID 10846832062017

TORNIER, INC.

Reverse shoulder prosthesis base plate Reverse shoulder prosthesis base plate Reverse shoulder prosthesis base plate Reverse shoulder prosthesis base plate Reverse shoulder prosthesis base plate Reverse shoulder prosthesis base plate Reverse shoulder prosthesis base plate Reverse shoulder prosthesis base plate Reverse shoulder prosthesis base plate Reverse shoulder prosthesis base plate Reverse shoulder prosthesis base plate Reverse shoulder prosthesis base plate Reverse shoulder prosthesis base plate Reverse shoulder prosthesis base plate Reverse shoulder prosthesis base plate Reverse shoulder prosthesis base plate Reverse shoulder prosthesis base plate Reverse shoulder prosthesis base plate Reverse shoulder prosthesis base plate Reverse shoulder prosthesis base plate Reverse shoulder prosthesis base plate Reverse shoulder prosthesis base plate Reverse shoulder prosthesis base plate Reverse shoulder prosthesis base plate

• Primary Device ID: 10846832062017
• NIH Device Record Key: 0b2cdf98-6932-4b8a-894c-0cc1d67e3fc7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tornier Perform® Reversed Augmented Glenoid
• Version Model Number: DWJ502
• Catalog Number: DWJ502
• Company DUNS: 968990812
• Company Name: TORNIER, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com

Device Dimensions

• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846832092123 [Primary]
GS1	10846832062017 [Package]; Contains: 00846832092123; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161742

FDA Product Code

• KWS: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-18
• Device Publish Date: 2022-05-10

On-Brand Devices [Tornier Perform® Reversed Augmented Glenoid]

• 10846832062048: DWJ504
• 10846832062055: DWJ515
• 10846832062031: DWJ514
• 10846832062017: DWJ502
• 10846832062062: DWJ505
• 10846832062024: DWJ503
• 10846832062000: DWJ513
• 10846832061997: DWJ512