TransLoc 3D

GUDID 00850026642070

TransLoc 3D Screw, 45mm

Foundation Fusion Solutions, LLC

Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, sterile

• Primary Device ID: 00850026642070
• NIH Device Record Key: af287a47-8839-4b29-ba3e-63d04ad409a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TransLoc 3D
• Version Model Number: TS85-45
• Company DUNS: 105361659
• Company Name: Foundation Fusion Solutions, LLC
• 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: 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: 888-743-8736
• Email: bob@cornerloc.com
• Phone: 888-743-8736
• Email: bob@cornerloc.com
• Phone: 888-743-8736
• Email: bob@cornerloc.com
• Phone: 888-743-8736
• Email: bob@cornerloc.com
• Phone: 888-743-8736
• Email: bob@cornerloc.com
• Phone: 888-743-8736
• Email: bob@cornerloc.com
• Phone: 888-743-8736
• Email: bob@cornerloc.com
• Phone: 888-743-8736
• Email: bob@cornerloc.com
• Phone: 888-743-8736
• Email: bob@cornerloc.com
• Phone: 888-743-8736
• Email: bob@cornerloc.com
• Phone: 888-743-8736
• Email: bob@cornerloc.com
• Phone: 888-743-8736
• Email: bob@cornerloc.com
• Phone: 888-743-8736
• Email: bob@cornerloc.com
• Phone: 888-743-8736
• Email: bob@cornerloc.com
• Phone: 888-743-8736
• Email: bob@cornerloc.com
• Phone: 888-743-8736
• Email: bob@cornerloc.com
• Phone: 888-743-8736
• Email: bob@cornerloc.com
• Phone: 888-743-8736
• Email: bob@cornerloc.com
• Phone: 888-743-8736
• Email: bob@cornerloc.com
• Phone: 888-743-8736
• Email: bob@cornerloc.com
• Phone: 888-743-8736
• Email: bob@cornerloc.com
• Phone: 888-743-8736
• Email: bob@cornerloc.com
• Phone: 888-743-8736
• Email: bob@cornerloc.com
• Phone: 888-743-8736
• Email: bob@cornerloc.com
• Phone: 888-743-8736
• Email: bob@cornerloc.com
• Phone: 888-743-8736
• Email: bob@cornerloc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850026642070 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211496

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: 2022-10-18
• Device Publish Date: 2022-10-10

On-Brand Devices [TransLoc 3D]

• 00850026642087: TransLoc 3D Screw, 50mm
• 00850026642070: TransLoc 3D Screw, 45mm