Latitude™ - Elbow DKY191

GUDID 00846832012459

TORNIER, INC.

Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis

• Primary Device ID: 00846832012459
• NIH Device Record Key: bda3b5ef-082a-46d9-bd15-5daf9cdbb204
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Latitude™ - Elbow
• Version Model Number: DKY191
• Catalog Number: DKY191
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846832012459 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070787

FDA Product Code

• JDB: PROSTHESIS, ELBOW, SEMI-CONSTRAINED, 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: 2022-04-08
• Device Publish Date: 2022-03-31

On-Brand Devices [Latitude™ - Elbow]

• 00846832012442: DKY186
• 00846832012435: DKY185
• 00846832012428: DKY184
• 00846832012411: DKY183
• 00846832012404: DKY182
• 00846832012398: DKY181
• 00846832012268: DKY087
• 00846832012251: DKY086
• 00846832012244: DKY085
• 00846832012237: DKY083
• 00846832012220: DKY082
• 00846832012213: DKY081
• 00846832012206: DKY077
• 00846832012190: DKY076
• 00846832012183: DKY075
• 00846832012176: DKY073
• 00846832012169: DKY072
• 00846832012152: DKY071
• 00846832011261: DKY228
• 00846832011254: DKY227
• 00846832011247: DKY226
• 00846832011230: DKY225
• 00846832011223: DKY224
• 00846832011216: DKY223
• 00846832011209: DKY222
• 00846832011193: DKY221
• 00846832011186: DKY218
• 00846832011179: DKY217
• 00846832011162: DKY216
• 00846832011155: DKY215
• 00846832011148: DKY214
• 00846832011131: DKY213
• 00846832011124: DKY212
• 00846832011117: DKY211
• 00846832011100: DKY208
• 00846832011094: DKY207
• 00846832011087: DKY206
• 00846832011070: DKY205
• 00846832011063: DKY204
• 00846832011056: DKY203
• 00846832011049: DKY202
• 00846832011032: DKY201
• 00846832011025: DKY125
• 00846832011018: DKY124
• 00846832011001: DKY123
• 00846832010998: DKY122
• 00846832010981: DKY121
• 00846832010974: DKY120
• 00846832010967: DKY059
• 00846832010950: DKY058