TOETAC HT-00001

GUDID 07613327356366

Hammertoe implant, Small

Stryker Trauma SA

Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable

• Primary Device ID: 07613327356366
• NIH Device Record Key: d8d70f8a-fcea-4fd7-8dfc-a529937b689c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TOETAC
• Version Model Number: HT-00001
• Catalog Number: HT-00001
• Company DUNS: 481999654
• Company Name: Stryker Trauma SA
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327356366 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150443

FDA Product Code

• HWC: Screw, fixation, bone

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: 2017-04-06

On-Brand Devices [TOETAC]

• 07613327356366: Hammertoe implant, Small
• 07613327356359: Hammertoe implant, Medium
• 07613327356304: Hammertoe implant, Large
• 07613327356298: Hammertoe Implant, Medium, 10 degree
• 07613327356229: Hammertoe Implant, Small, 10 degree
• 07613327356151: Hammertoe Implant, Large, 10 degree
• 07613327356106: Hammertoe Implant Removal Tool