iFuse TORQ Implant System

GUDID 00810055520138

10.0mm x 85mm iFuse-TORQ

Si-Bone Inc.

Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated

• Primary Device ID: 00810055520138
• NIH Device Record Key: 46909a54-14cd-4930-8f2a-0649464c1dd6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iFuse TORQ Implant System
• Version Model Number: 10085T
• 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: 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

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
• 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 Dimensions

• Length: 85 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 85 Millimeter
• Outer Diameter: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810055520138 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203247

FDA Product Code

• OUR: Sacroiliac Joint Fixation

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-16
• Device Publish Date: 2021-03-08

On-Brand Devices [iFuse TORQ Implant System]

• 00810055520732: 13.5 mm x 90 mm iFuse-TORQ, Lag
• 00810055520725: 13.5 mm x 85 mm iFuse-TORQ, Lag
• 00810055520718: 13.5 mm x 80 mm iFuse-TORQ, Lag
• 00810055520701: 13.5 mm x 75 mm iFuse-TORQ, Lag
• 00810055520695: 13.5 mm x 70 mm iFuse-TORQ, Lag
• 00810055520688: 13.5 mm x 65 mm iFuse-TORQ, Lag
• 00810055520671: 13.5 mm x 60 mm iFuse-TORQ, Lag
• 00810055520664: 13.5 mm x 55 mm iFuse-TORQ, Lag
• 00810055520657: 13.5 mm x 50 mm iFuse-TORQ, Lag
• 00810055520640: 13.5 mm x 45 mm iFuse-TORQ, Lag
• 00810055520633: 13.5 mm x 40 mm iFuse-TORQ, Lag
• 00810055520626: 13.5 mm x 90 mm iFuse-TORQ
• 00810055520619: 13.5 mm x 85 mm iFuse-TORQ
• 00810055520602: 13.5 mm x 80 mm iFuse-TORQ
• 00810055520596: 13.5 mm x 75 mm iFuse-TORQ
• 00810055520589: 13.5 mm x 70 mm iFuse-TORQ
• 00810055520572: 13.5 mm x 65 mm iFuse-TORQ
• 00810055520565: 13.5 mm x 60 mm iFuse-TORQ
• 00810055520558: 13.5 mm x 55 mm iFuse-TORQ
• 00810055520541: 13.5 mm x 50 mm iFuse-TORQ
• 00810055520534: 13.5 mm x 45 mm iFuse-TORQ
• 00810055520527: 13.5 mm x 40 mm iFuse-TORQ
• 00810055520510: 13.5 mm x 35 mm iFuse-TORQ
• 00810055520503: 13.5 mm x 30 mm iFuse-TORQ
• 00810055520497: 11.5 mm x 90 mm iFuse-TORQ, Lag
• 00810055520480: 11.5 mm x 85 mm iFuse-TORQ, Lag
• 00810055520473: 11.5 mm x 80 mm iFuse-TORQ, Lag
• 00810055520466: 11.5 mm x 75 mm iFuse-TORQ, Lag
• 00810055520459: 11.5 mm x 70 mm iFuse-TORQ, Lag
• 00810055520442: 11.5 mm x 65 mm iFuse-TORQ, Lag
• 00810055520435: 11.5 mm x 60 mm iFuse-TORQ, Lag
• 00810055520428: 11.5 mm x 55 mm iFuse-TORQ, Lag
• 00810055520411: 11.5 mm x 50 mm iFuse-TORQ, Lag
• 00810055520404: 11.5 mm x 45 mm iFuse-TORQ, Lag
• 00810055520398: 11.5 mm x 40 mm iFuse-TORQ, Lag
• 00810055520381: 11.5 mm x 90 mm iFuse-TORQ
• 00810055520374: 11.5 mm x 85 mm iFuse-TORQ
• 00810055520367: 11.5 mm x 80 mm iFuse-TORQ
• 00810055520350: 11.5 mm x 75 mm iFuse-TORQ
• 00810055520343: 11.5 mm x 70 mm iFuse-TORQ
• 00810055520336: 11.5 mm x 65 mm iFuse-TORQ
• 00810055520329: 11.5 mm x 60 mm iFuse-TORQ
• 00810055520312: 11.5 mm x 55 mm iFuse-TORQ
• 00810055520305: 11.5 mm x 50 mm iFuse-TORQ
• 00810055520299: 11.5 mm x 45 mm iFuse-TORQ
• 00810055520282: 11.5 mm x 40 mm iFuse-TORQ
• 00810055520275: 11.5 mm x 35 mm iFuse-TORQ
• 00810055520268: 11.5 mm x 30 mm iFuse-TORQ
• 00810055520251: 10.0 mm x 90 mm iFuse-TORQ, Lag
• 00810055520244: 10.0 mm x 85 mm iFuse-TORQ, Lag