8mm Twist Subtalar Implant

GUDID 00812926020242

TRILLIANT SURGICAL, LTD.

Subtalar implant, non-bioabsorbable, sterile

• Primary Device ID: 00812926020242
• NIH Device Record Key: 8c792867-14a9-4309-b6e1-11a66956916e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 8mm Twist Subtalar Implant
• Version Model Number: 102-10-008
• Company DUNS: 828829072
• Company Name: TRILLIANT SURGICAL, LTD.
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Height: 13.5 Millimeter
• Height: 13.5 Millimeter
• Height: 13.5 Millimeter
• Height: 13.5 Millimeter
• Width: 8 Millimeter
• Height: 13.5 Millimeter
• Width: 8 Millimeter
• Height: 13.5 Millimeter
• Width: 8 Millimeter
• Height: 13.5 Millimeter
• Width: 8 Millimeter
• Height: 13.5 Millimeter
• Width: 8 Millimeter
• Height: 13.5 Millimeter
• Width: 8 Millimeter
• Height: 13.5 Millimeter
• Width: 8 Millimeter
• Height: 13.5 Millimeter
• Width: 8 Millimeter
• Height: 13.5 Millimeter
• Width: 8 Millimeter
• Height: 13.5 Millimeter
• Width: 8 Millimeter
• Height: 13.5 Millimeter
• Width: 8 Millimeter
• Height: 13.5 Millimeter
• Width: 8 Millimeter
• Height: 13.5 Millimeter
• Width: 8 Millimeter
• Height: 13.5 Millimeter
• Width: 8 Millimeter
• Height: 13.5 Millimeter
• Width: 8 Millimeter
• Height: 13.5 Millimeter
• Width: 8 Millimeter
• Height: 13.5 Millimeter
• Width: 8 Millimeter
• Height: 13.5 Millimeter
• Width: 8 Millimeter
• Height: 13.5 Millimeter
• Width: 8 Millimeter
• Height: 13.5 Millimeter
• Width: 8 Millimeter
• Height: 13.5 Millimeter
• Width: 8 Millimeter
• Height: 13.5 Millimeter
• Width: 8 Millimeter
• Height: 13.5 Millimeter
• Width: 8 Millimeter
• Height: 13.5 Millimeter
• Width: 8 Millimeter
• Height: 13.5 Millimeter
• Width: 8 Millimeter
• Height: 13.5 Millimeter
• Width: 8 Millimeter
• Height: 13.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812926020242 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103183

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00812926020242]

Moist Heat or Steam Sterilization

[00812926020242]

Moist Heat or Steam Sterilization

[00812926020242]

Moist Heat or Steam Sterilization

[00812926020242]

Moist Heat or Steam Sterilization

[00812926020242]

Moist Heat or Steam Sterilization

[00812926020242]

Moist Heat or Steam Sterilization

[00812926020242]

Moist Heat or Steam Sterilization

[00812926020242]

Moist Heat or Steam Sterilization

[00812926020242]

Moist Heat or Steam Sterilization

[00812926020242]

Moist Heat or Steam Sterilization

[00812926020242]

Moist Heat or Steam Sterilization

[00812926020242]

Moist Heat or Steam Sterilization

[00812926020242]

Moist Heat or Steam Sterilization

[00812926020242]

Moist Heat or Steam Sterilization

[00812926020242]

Moist Heat or Steam Sterilization

[00812926020242]

Moist Heat or Steam Sterilization

[00812926020242]

Moist Heat or Steam Sterilization

[00812926020242]

Moist Heat or Steam Sterilization

[00812926020242]

Moist Heat or Steam Sterilization

[00812926020242]

Moist Heat or Steam Sterilization

[00812926020242]

Moist Heat or Steam Sterilization

[00812926020242]

Moist Heat or Steam Sterilization

[00812926020242]

Moist Heat or Steam Sterilization

[00812926020242]

Moist Heat or Steam Sterilization

[00812926020242]

Moist Heat or Steam Sterilization

[00812926020242]

Moist Heat or Steam Sterilization

[00812926020242]

Moist Heat or Steam Sterilization

[00812926020242]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-27

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