Latitude™ - Elbow DKY192

GUDID 00846832012466

TORNIER, INC.

Hinged total elbow prosthesis

• Primary Device ID: 00846832012466
• NIH Device Record Key: 8f21ac82-03aa-4c16-a61e-2d9f6fc8978e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Latitude™ - Elbow
• Version Model Number: DKY192
• Catalog Number: DKY192
• 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	00846832012466 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070787

FDA Product Code

• JDC: PROSTHESIS, ELBOW, 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