SacroFuse®

GUDID 00190361039587

INSERTER, SACROFUSE

SPINEFRONTIER, INC.

Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, sterile

• Primary Device ID: 00190361039587
• NIH Device Record Key: e7841d06-d5c3-4dba-92f0-e49f225c0eae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SacroFuse®
• Version Model Number: 13-42000
• 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: 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: +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 Identifiers

Device Issuing Agency	Device ID
GS1	00190361039587 [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

[00190361039587]

Moist Heat or Steam Sterilization

[00190361039587]

Moist Heat or Steam Sterilization

[00190361039587]

Moist Heat or Steam Sterilization

[00190361039587]

Moist Heat or Steam Sterilization

[00190361039587]

Moist Heat or Steam Sterilization

[00190361039587]

Moist Heat or Steam Sterilization

[00190361039587]

Moist Heat or Steam Sterilization

[00190361039587]

Moist Heat or Steam Sterilization

[00190361039587]

Moist Heat or Steam Sterilization

[00190361039587]

Moist Heat or Steam Sterilization

[00190361039587]

Moist Heat or Steam Sterilization

[00190361039587]

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: 2016-10-05

Devices Manufactured by SPINEFRONTIER, INC.

• 00190361029403 - SacroFuse: 2021-09-07 Ø8MM X 80 MM FUSION SCREW, GEN II, SCAROFUSE
• 00190361029410 - SacroFuse: 2021-09-07 Ø8MM X 90 MM FUSION SCREW, GEN II, SCAROFUSE
• 00190361029427 - SacroFuse: 2021-09-07 Ø8MM X 100 MM FUSION SCREW, GEN II, SCAROFUSE
• 00190361029434 - SacroFuse: 2021-09-07 Ø8MM X 110 MM FUSION SCREW, GEN II, SCAROFUSE
• 00190361029441 - SacroFuse: 2021-09-07 Ø8MM X 120 MM FUSION SCREW, GEN II, SCAROFUSE
• 00190361029458 - SacroFuse: 2021-09-07 Ø8MM X 130 MM FUSION SCREW, GEN II, SCAROFUSE
• 00190361029465 - SacroFuse: 2021-09-07 Ø10MM X 80MM SLOTTED FUSION SCREW, GEN II, SACROFUSE
• 00190361029472 - SacroFuse: 2021-09-07 Ø10MM X 90MM SLOTTED FUSION SCREW, GEN II, SACROFUSE