Aequalis™ Ascend™ PTC

GUDID 00846832060580

TORNIER, INC.

Coated shoulder humeral stem prosthesis

• Primary Device ID: 00846832060580
• NIH Device Record Key: d40ee508-0574-4967-9031-1776b6bd09ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aequalis™ Ascend™ PTC
• Version Model Number: 7503305C
• 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: false
• 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
• 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

• Angle: 137.5 degree
• Angle: 137.5 degree
• Angle: 137.5 degree
• Device Size Text, specify: 0
• Length: 82 Millimeter
• Angle: 137.5 degree
• Device Size Text, specify: 0
• Length: 82 Millimeter
• Angle: 137.5 degree
• Device Size Text, specify: 0
• Length: 82 Millimeter
• Angle: 137.5 degree
• Device Size Text, specify: 0
• Length: 82 Millimeter
• Angle: 137.5 degree
• Device Size Text, specify: 0
• Length: 82 Millimeter
• Angle: 137.5 degree
• Device Size Text, specify: 0
• Length: 82 Millimeter
• Angle: 137.5 degree
• Device Size Text, specify: 0
• Length: 82 Millimeter
• Angle: 137.5 degree
• Device Size Text, specify: 0
• Length: 82 Millimeter
• Angle: 137.5 degree
• Device Size Text, specify: 0
• Length: 82 Millimeter
• Angle: 137.5 degree
• Device Size Text, specify: 0
• Length: 82 Millimeter
• Angle: 137.5 degree
• Device Size Text, specify: 0
• Length: 82 Millimeter
• Angle: 137.5 degree
• Device Size Text, specify: 0
• Length: 82 Millimeter
• Angle: 137.5 degree
• Device Size Text, specify: 0
• Length: 82 Millimeter
• Angle: 137.5 degree
• Device Size Text, specify: 0
• Length: 82 Millimeter
• Angle: 137.5 degree
• Device Size Text, specify: 0
• Length: 82 Millimeter
• Angle: 137.5 degree
• Device Size Text, specify: 0
• Length: 82 Millimeter
• Angle: 137.5 degree
• Device Size Text, specify: 0
• Length: 82 Millimeter
• Angle: 137.5 degree
• Device Size Text, specify: 0
• Length: 82 Millimeter
• Angle: 137.5 degree
• Device Size Text, specify: 0
• Length: 82 Millimeter
• Angle: 137.5 degree
• Device Size Text, specify: 0
• Length: 82 Millimeter
• Angle: 137.5 degree
• Device Size Text, specify: 0
• Length: 82 Millimeter
• Angle: 137.5 degree
• Device Size Text, specify: 0
• Length: 82 Millimeter
• Angle: 137.5 degree
• Device Size Text, specify: 0
• Length: 82 Millimeter
• Angle: 137.5 degree
• Device Size Text, specify: 0
• Length: 82 Millimeter
• Angle: 137.5 degree
• Device Size Text, specify: 0
• Length: 82 Millimeter
• Angle: 137.5 degree
• Device Size Text, specify: 0
• Length: 82 Millimeter
• Angle: 137.5 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846832060580 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120794

FDA Product Code

• KWT: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-16

On-Brand Devices [Aequalis™ Ascend™ PTC]

• 00846832060702: 7503309C
• 00846832060696: 7503309B
• 00846832060689: 7503309A
• 00846832060672: 7503308C
• 00846832060665: 7503308B
• 00846832060658: 7503308A
• 00846832060641: 7503307C
• 00846832060634: 7503307B
• 00846832060627: 7503307A
• 00846832060610: 7503306C
• 00846832060603: 7503306B
• 00846832060597: 7503306A
• 00846832060580: 7503305C
• 00846832060573: 7503305B
• 00846832060566: 7503305A
• 00846832060559: 7503304C
• 00846832060542: 7503304B
• 00846832060535: 7503304A
• 00846832060528: 7503303C
• 00846832060511: 7503303B
• 00846832060504: 7503303A
• 00846832060498: 7503302C
• 00846832060481: 7503302B
• 00846832060474: 7503302A
• 00846832060467: 7503301C
• 00846832060450: 7503301B
• 00846832060443: 7503301A