VALOR

GUDID 00840420115867

WRIGHT MEDICAL TECHNOLOGY, INC.

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00840420115867
• NIH Device Record Key: 18fe8c84-7a2b-465e-8bba-d2123b9b1e66
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VALOR
• Version Model Number: 4151150080
• Company DUNS: 807201207
• Company Name: WRIGHT MEDICAL TECHNOLOGY, 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com
• Phone: +1(800)238-7117
• Email: customerservice@wmt.com

Device Dimensions

• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840420115867 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090857

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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: 2015-10-01

On-Brand Devices [VALOR]

• 00889797035392: 4150005002
• 00889797035590: 4150011012
• 00889797035552: 4150011002
• 00840420125613: 415101125R
• 00840420125606: 415101125L
• 00840420125590: 415101120R
• 00840420125583: 415101120L
• 00840420125576: 415101115R
• 00840420125569: 415101115L
• 00840420125552: 415101030R
• 00840420125545: 415101030L
• 00840420125538: 415101025R
• 00840420125521: 415101025L
• 00840420125514: 415101020R
• 00840420125507: 415101020L
• 00840420125491: 415101015R
• 00840420125484: 415101015L
• 00840420124364: 4151200003
• 00840420124357: 4151200002
• 00840420124340: 4151200001
• 00840420115997: 4151150115
• 00840420115980: 4151150105
• 00840420115973: 4151150120
• 00840420115966: 4151150110
• 00840420115959: 4151150020
• 00840420115942: 4151150095
• 00840420115935: 4151150055
• 00840420115928: 4151150100
• 00840420115911: 4151150060
• 00840420115904: 4151150050
• 00840420115898: 4151150090
• 00840420115881: 4151150065
• 00840420115874: 4151150085
• 00840420115867: 4151150080
• 00840420115850: 4151150045
• 00840420115843: 4151150075
• 00840420115836: 4151150070
• 00840420115829: 4151150040
• 00840420115812: 4151150025
• 00840420115805: 4151150035
• 00840420115799: 4151150030
• 00840420125637: 415101130R
• 00889797057103: 415S002352
• 00889797057097: 415S002351
• 00889797056724: 415S002350
• 00889797035644: 4150016000
• 00889797035484: 4150006125
• 00889797035477: 4150006120
• 00889797035460: 4150006115
• 00889797035453: 4150006110