ORTHOFLEX

GUDID 00840420170378

WRIGHT MEDICAL TECHNOLOGY, INC.

Interphalangeal joint arthrodesis implant

• Primary Device ID: 00840420170378
• NIH Device Record Key: b76f80ee-89df-4992-86ae-5fceb7bcd207
• Commercial Distribution Discontinuation: 2016-04-25
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ORTHOFLEX
• Version Model Number: 04-004
• 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

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840420170378 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102601

FDA Product Code

• KWH: PROSTHESIS, TOE, CONSTRAINED, POLYMER

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 [ORTHOFLEX]

• 00840420170378: 04-004
• 00840420170361: 04-003
• 00840420170354: 04-002
• 00840420170347: 04-001