TransLoc 3D

GUDID 00850026642117

T-Handle

Foundation Fusion Solutions, LLC

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 00850026642117
• NIH Device Record Key: ac8eacbf-229b-4c34-9ecd-6ccc91cf0d74
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TransLoc 3D
• Version Model Number: S01-02
• 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: 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: 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	00850026642117 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211496

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00850026642117]

Moist Heat or Steam Sterilization

[00850026642117]

Moist Heat or Steam Sterilization

[00850026642117]

Moist Heat or Steam Sterilization

[00850026642117]

Moist Heat or Steam Sterilization

[00850026642117]

Moist Heat or Steam Sterilization

[00850026642117]

Moist Heat or Steam Sterilization

[00850026642117]

Moist Heat or Steam Sterilization

[00850026642117]

Moist Heat or Steam Sterilization

[00850026642117]

Moist Heat or Steam Sterilization

[00850026642117]

Moist Heat or Steam Sterilization

[00850026642117]

Moist Heat or Steam Sterilization

[00850026642117]

Moist Heat or Steam Sterilization

[00850026642117]

Moist Heat or Steam Sterilization

[00850026642117]

Moist Heat or Steam Sterilization

[00850026642117]

Moist Heat or Steam Sterilization

[00850026642117]

Moist Heat or Steam Sterilization

[00850026642117]

Moist Heat or Steam Sterilization

[00850026642117]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-25
• Device Publish Date: 2023-10-17

On-Brand Devices [TransLoc 3D ]

• 00850026642094: TransLoc 3D Screw, 55mm
• 00850026642063: TransLoc 3D Screw, 40mm
• 00850026642056: TransLoc 3D Screw, 35mm
• 00850026642049: TransLoc 3D Implant, 30mm
• 00850026642032: TransLoc 3D Implant, 25mm
• 00850026642025: TransLoc 3D Implant, 20mm
• 00850026642292: 1/4 inch to Jacobs Drill Adapter
• 00850026642261: Graft Holder
• 00850026642254: Tray Base
• 00850026642247: Tray Lid
• 00850026642230: .040" x 12" Guidewire
• 00850026642223: Screwdriver
• 00850026642216: Ratcheting T-Handle
• 00850026642209: Reamer
• 00850026642193: Trocar
• 00850026642179: Steinmann Pin 2.4mm, Trocar/Round 9”
• 00850026642162: Hammer Shaft
• 00850026642155: Hammer Tube
• 00850026642148: Broach, Square w/ Rounded Pilot Tip
• 00850026642131: Drill, End and Side Cutting, 5/16
• 00850026642124: Retraction Guide Tube
• 00850026642117: T-Handle
• 00850026642100: Joint Finder/Dilator
• 00850026642018: Inserter Shaft
• 00850026642001: Inserter with Key Bump
• 00850026642360: TRANSLOC 3D SCREW, Ø9.5mm x 60mm
• 00850026642353: TRANSLOC 3D SCREW, Ø9.5mm x 55mm
• 00850026642346: TRANSLOC 3D SCREW, Ø9.5mm x 50mm
• 00850026642339: TRANSLOC 3D SCREW, Ø9.5mm x 45mm
• 00850026642322: TRANSLOC 3D SCREW, Ø9.5mm x 40mm
• 00850026642315: TRANSLOC 3D SCREW, Ø9.5mm x 35mm
• 00850026642308: TRANSLOC 3D SCREW, Ø8.5mm x 60mm