SacroFuse

GUDID 00190361023388

Ø10MM SLOTTED FUSION SCREW, GEN II, SACROFUSE, 35MM

SPINEFRONTIER, INC.

Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, sterile

• Primary Device ID: 00190361023388
• NIH Device Record Key: 99cd0b61-755c-47f3-a1f1-b078c54533dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SacroFuse
• Version Model Number: 01-42401-35
• Company DUNS: 002003243
• Company Name: SPINEFRONTIER, INC.
• Device Count: 1
• DM Exempt: true
• 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

Customer Support Contacts

• Phone: +1(866)914-7717
• Email: customerservice@spinefrontier.com
• Phone: +1(866)914-7717
• Email: customerservice@spinefrontier.com
• Phone: +1(866)914-7717
• Email: customerservice@spinefrontier.com
• Phone: +1(866)914-7717
• Email: customerservice@spinefrontier.com
• Phone: +1(866)914-7717
• Email: customerservice@spinefrontier.com
• Phone: +1(866)914-7717
• Email: customerservice@spinefrontier.com
• Phone: +1(866)914-7717
• Email: customerservice@spinefrontier.com
• Phone: +1(866)914-7717
• Email: customerservice@spinefrontier.com
• Phone: +1(866)914-7717
• Email: customerservice@spinefrontier.com
• Phone: +1(866)914-7717
• Email: customerservice@spinefrontier.com
• Phone: +1(866)914-7717
• Email: customerservice@spinefrontier.com
• Phone: +1(866)914-7717
• Email: customerservice@spinefrontier.com

Device Dimensions

• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 35 Millimeter
• Outer Diameter: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190361023388 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150017

FDA Product Code

• OUR: Sacroiliac joint fixation

Sterilization

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

[00190361023388]

Moist Heat or Steam Sterilization

[00190361023388]

Moist Heat or Steam Sterilization

[00190361023388]

Moist Heat or Steam Sterilization

[00190361023388]

Moist Heat or Steam Sterilization

[00190361023388]

Moist Heat or Steam Sterilization

[00190361023388]

Moist Heat or Steam Sterilization

[00190361023388]

Moist Heat or Steam Sterilization

[00190361023388]

Moist Heat or Steam Sterilization

[00190361023388]

Moist Heat or Steam Sterilization

[00190361023388]

Moist Heat or Steam Sterilization

[00190361023388]

Moist Heat or Steam Sterilization

[00190361023388]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-07-09
• Device Publish Date: 2018-06-08

On-Brand Devices [SacroFuse]

• 00190361036289: SCREW, SOLID WALL, CANNULATED, Ø12MM X 70MM, SACROFUSE
• 00190361036272: SCREW, SOLID WALL, CANNULATED, Ø12MM X 65MM, SACROFUSE
• 00190361036265: SCREW, SOLID WALL, CANNULATED, Ø12MM X 60MM, SACROFUSE
• 00190361036258: SCREW, SOLID WALL, CANNULATED, Ø12MM X 55MM, SACROFUSE
• 00190361036241: SCREW, SOLID WALL, CANNULATED, Ø12MM X 50MM, SACROFUSE
• 00190361036234: SCREW, SOLID WALL, CANNULATED, Ø12MM X 45MM, SACROFUSE
• 00190361036227: SCREW, SOLID WALL, CANNULATED, Ø12MM X 40MM, SACROFUSE
• 00190361036210: SCREW, SOLID WALL, CANNULATED, Ø12MM X 35MM, SACROFUSE
• 00190361036203: SCREW, SOLID WALL, CANNULATED, Ø12MM X 30MM, SACROFUSE
• 00190361036197: SCREW, SOLID WALL, CANNULATED, Ø10MM X 70MM, SACROFUSE
• 00190361036180: SCREW, SOLID WALL, CANNULATED, Ø10MM X 65MM, SACROFUSE
• 00190361036173: SCREW, SOLID WALL, CANNULATED, Ø10MM X 60MM, SACROFUSE
• 00190361036166: SCREW, SOLID WALL, CANNULATED, Ø10MM X 55MM, SACROFUSE
• 00190361036159: SCREW, SOLID WALL, CANNULATED, Ø10MM X 50MM, SACROFUSE
• 00190361036142: SCREW, SOLID WALL, CANNULATED, Ø10MM X 45MM, SACROFUSE
• 00190361036135: SCREW, SOLID WALL, CANNULATED, Ø10MM X 40MM, SACROFUSE
• 00190361036128: SCREW, SOLID WALL, CANNULATED, Ø10MM X 35MM, SACROFUSE
• 00190361036111: SCREW, SOLID WALL, CANNULATED, Ø10MM X 30MM, SACROFUSE
• 00190361036104: SCREW, SOLID WALL, CANNULATED, Ø8MM X 70MM, SACROFUSE
• 00190361036098: SCREW, SOLID WALL, CANNULATED, Ø8MM X 65MM, SACROFUSE
• 00190361036081: SCREW, SOLID WALL, CANNULATED, Ø8MM X 60MM, SACROFUSE
• 00190361036074: SCREW, SOLID WALL, CANNULATED, Ø8MM X 55MM, SACROFUSE
• 00190361036067: SCREW, SOLID WALL, CANNULATED, Ø8MM X 50MM, SACROFUSE
• 00190361036050: SCREW, SOLID WALL, CANNULATED, Ø8MM X 45MM, SACROFUSE
• 00190361036043: SCREW, SOLID WALL, CANNULATED, Ø8MM X 40MM, SACROFUSE
• 00190361036036: SCREW, SOLID WALL, CANNULATED, Ø8MM X 35MM, SACROFUSE
• 00190361036029: SCREW, SOLID WALL, CANNULATED, Ø8MM X 30MM, SACROFUSE
• 00190361036012: FENESTRATED SCREW, CANNULATED, Ø10MM x 70MM, SACROFUSE
• 00190361036005: FENESTRATED SCREW, CANNULATED, Ø10MM x 65MM, SACROFUSE
• 00190361035992: FENESTRATED SCREW, CANNULATED, Ø10MM x 60MM, SACROFUSE
• 00190361035985: FENESTRATED SCREW, CANNULATED, Ø10MM x 55MM, SACROFUSE
• 00190361035978: FENESTRATED SCREW, CANNULATED, Ø10MM x 50MM, SACROFUSE
• 00190361035961: FENESTRATED SCREW, CANNULATED, Ø10MM x 45MM, SACROFUSE
• 00190361035954: FENESTRATED SCREW, CANNULATED, Ø10MM x 40MM, SACROFUSE
• 00190361035947: FENESTRATED SCREW, CANNULATED, Ø10MM x 35MM, SACROFUSE
• 00190361035930: FENESTRATED SCREW, CANNULATED, Ø10MM x 30MM, SACROFUSE
• 00190361035923: FENESTRATED SCREW, CANNULATED, Ø12MM x 70MM, SACROFUSE
• 00190361035916: FENESTRATED SCREW, CANNULATED, Ø12MM x 65MM, SACROFUSE
• 00190361035909: FENESTRATED SCREW, CANNULATED, Ø12MM x 60MM, SACROFUSE
• 00190361035893: FENESTRATED SCREW, CANNULATED, Ø12MM x 55MM, SACROFUSE
• 00190361035886: FENESTRATED SCREW, CANNULATED, Ø12MM x 45MM, SACROFUSE
• 00190361035879: FENESTRATED SCREW, CANNULATED, Ø12MM x 35MM, SACROFUSE
• 00190361035862: FENESTRATED SCREW, CANNULATED, Ø12MM x 50MM, SACROFUSE
• 00190361035855: FENESTRATED SCREW, CANNULATED, Ø12MM x 40MM, SACROFUSE
• 00190361035848: FENESTRATED SCREW, CANNULATED, Ø12MM x 30MM, SACROFUSE
• 00190361023647: DRIVER, GEN II INSERTER, SACROFUSE
• 00190361023630: STYLET, GEN II INSERTER, SACROFUSE
• 00190361023623: Ø14MM SLOTTED FUSION SCREW, GEN II, SACROFUSE, 70MM
• 00190361023616: Ø14MM SLOTTED FUSION SCREW, GEN II, SACROFUSE, 65MM
• 00190361023609: Ø14MM SLOTTED FUSION SCREW, GEN II, SACROFUSE, 60MM