SUBFIX SUT0080

GUDID 07613252263524

Arthroeresis Implant

Stryker Trauma SA

Orthopaedic bone staple, non-adjustable, non-sterile

• Primary Device ID: 07613252263524
• NIH Device Record Key: 9a457b3b-ff9d-4357-846f-8b032e29657c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SUBFIX
• Version Model Number: SUT0080
• Catalog Number: SUT0080
• 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: 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

• 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	07613252263524 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093820

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[07613252263524]

Moist Heat or Steam Sterilization

[07613252263524]

Moist Heat or Steam Sterilization

[07613252263524]

Moist Heat or Steam Sterilization

[07613252263524]

Moist Heat or Steam Sterilization

[07613252263524]

Moist Heat or Steam Sterilization

[07613252263524]

Moist Heat or Steam Sterilization

[07613252263524]

Moist Heat or Steam Sterilization

[07613252263524]

Moist Heat or Steam Sterilization

[07613252263524]

Moist Heat or Steam Sterilization

[07613252263524]

Moist Heat or Steam Sterilization

[07613252263524]

Moist Heat or Steam Sterilization

[07613252263524]

Moist Heat or Steam Sterilization

[07613252263524]

Moist Heat or Steam Sterilization

[07613252263524]

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: 2015-09-24

On-Brand Devices [SUBFIX]

• 07613252264866: Trial
• 07613252264859: Trial
• 07613252264842: Trial
• 07613252264835: Trial
• 07613252264828: Trial
• 07613252263531: Arthroeresis Implant
• 07613252263524: Arthroeresis Implant
• 07613252263517: Arthroeresis Implant
• 07613252263500: Arthroeresis Implant
• 07613252263494: Arthroeresis Implant
• 07613252266990: Insertion Driver
• 07613252266754: Ancillary Set
• 07613252266433: Tray with Lid
• 07613252264729: Removal Driver
• 07613252264545: Guidewire