Aequalis™ Adjustable Reversed

GUDID 00846832068333

TORNIER, INC.

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile

• Primary Device ID: 00846832068333
• NIH Device Record Key: 0ff7b451-8a00-4c7f-8977-8baf31cdcb3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aequalis™ Adjustable Reversed
• Version Model Number: 6401120
• 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

Device Dimensions

• Length: 120 Millimeter
• Length: 120 Millimeter
• Length: 120 Millimeter
• Length: 120 Millimeter
• Length: 120 Millimeter
• Length: 120 Millimeter
• Length: 120 Millimeter
• Length: 120 Millimeter
• Length: 120 Millimeter
• Length: 120 Millimeter
• Length: 120 Millimeter
• Length: 120 Millimeter
• Length: 120 Millimeter
• Length: 120 Millimeter
• Length: 120 Millimeter
• Length: 120 Millimeter
• Length: 120 Millimeter
• Length: 120 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846832068333 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141029

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-09

On-Brand Devices [Aequalis™ Adjustable Reversed]

• 00846832068401: 6401170
• 00846832068395: 6401160
• 00846832068388: 6401155
• 00846832068371: 6401150
• 00846832068364: 6401140
• 00846832068357: 6401135
• 00846832068340: 6401125
• 00846832068333: 6401120
• 00846832068326: 6401110
• 00846832068319: 6401105
• 00846832068302: 6131710
• 00846832068296: 6131510
• 00846832068289: 6131310
• 00846832068272: 6131110
• 00846832068265: 6130910
• 00846832068258: 6121790
• 00846832068241: 6121710
• 00846832068234: 6121590
• 00846832068227: 6121510
• 00846832068210: 6121390
• 00846832068203: 6121310
• 00846832068197: 6121110
• 00846832068180: 6120990
• 00846832068173: 6120910
• 00846832068166: 6101790
• 00846832068159: 6101710
• 00846832068142: 6101590
• 00846832068135: 6101510
• 00846832068128: 6101390
• 00846832068111: 6101310
• 00846832068104: 6101190
• 00846832068098: 6101110
• 00846832068081: 6100990
• 00846832068074: 6100910
• 00846832060436: 6603617
• 00846832060429: 6603615
• 00846832060412: 6603613
• 00846832060405: 6603611
• 00846832060399: 6603609
• 00846832060382: 6501750
• 00846832060375: 6501725
• 00846832060368: 6501720
• 00846832060351: 6501715
• 00846832060344: 6501700
• 00846832060337: 6501550
• 00846832060320: 6501525
• 00846832060313: 6501520
• 00846832060306: 6501515
• 00846832060290: 6501500
• 00846832060283: 6501350