Affiniti™ PC

GUDID 00846832003013

TORNIER, INC.

Coated shoulder humeral stem prosthesis

• Primary Device ID: 00846832003013
• NIH Device Record Key: dd0c1165-5daf-4b7b-94f0-2d70085f71de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Affiniti™ PC
• Version Model Number: 1122227
• 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
• 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

• Length: 110 Millimeter
• Length: 110 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 110 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 110 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 110 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 110 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 110 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 110 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 110 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 110 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 110 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 110 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 110 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 110 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 110 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 110 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 110 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 110 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 110 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 110 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 110 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 110 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 110 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 110 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 110 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 110 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 110 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 110 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 110 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 110 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 110 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 110 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 110 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 110 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 110 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846832003013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103007

FDA Product Code

• HSD: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

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 [Affiniti™ PC]

• 00846832003105: 1122236
• 00846832003099: 1122235
• 00846832003082: 1122234
• 00846832003075: 1122233
• 00846832003068: 1122232
• 00846832003051: 1122231
• 00846832003044: 1122230
• 00846832003037: 1122229
• 00846832003020: 1122228
• 00846832003013: 1122227
• 00846832003006: 1122226