iFuse TORQ Implant System-iFuse-iFuse-TORQ Fluro Instrument Set

GUDID 00810055524198

iFuse-TORQ Fluro Instrument Set

Si-Bone Inc.

Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit

• Primary Device ID: 00810055524198
• NIH Device Record Key: 710ffd5a-9691-49ce-ab5d-5ff2aae9aeb9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iFuse TORQ Implant System-iFuse-iFuse-TORQ Fluro Instrument Set
• Version Model Number: 400451
• Company DUNS: 830127168
• Company Name: Si-Bone Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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

Customer Support Contacts

• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810055524198 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203247

FDA Product Code

• OUR: Sacroiliac Joint Fixation

Sterilization

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

[00810055524198]

Moist Heat or Steam Sterilization

[00810055524198]

Moist Heat or Steam Sterilization

[00810055524198]

Moist Heat or Steam Sterilization

[00810055524198]

Moist Heat or Steam Sterilization

[00810055524198]

Moist Heat or Steam Sterilization

[00810055524198]

Moist Heat or Steam Sterilization

[00810055524198]

Moist Heat or Steam Sterilization

[00810055524198]

Moist Heat or Steam Sterilization

[00810055524198]

Moist Heat or Steam Sterilization

[00810055524198]

Moist Heat or Steam Sterilization

[00810055524198]

Moist Heat or Steam Sterilization

[00810055524198]

Moist Heat or Steam Sterilization

[00810055524198]

Moist Heat or Steam Sterilization

[00810055524198]

Moist Heat or Steam Sterilization

[00810055524198]

Moist Heat or Steam Sterilization

[00810055524198]

Moist Heat or Steam Sterilization

[00810055524198]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-10
• Device Publish Date: 2023-11-02

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