Restore Interbody Fusion System RETL-28S1106P

GUDID B07511002228S1106P0

Small Lordotic TLIF Cage - PEEK 28mm(L) x 9mm(W) x 11mm(H) x 6*(A)

Republic Spine, LLC

Polymeric spinal interbody fusion cage

• Primary Device ID: B07511002228S1106P0
• NIH Device Record Key: 9d31b68e-75ae-494c-9343-4581dab7d50e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Restore Interbody Fusion System
• Version Model Number: 110022-28S1106P
• Catalog Number: RETL-28S1106P
• Company DUNS: 061891717
• Company Name: Republic Spine, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 727-512-5461
• Email: james@rspine.com
• Phone: 727-512-5461
• Email: james@rspine.com
• Phone: 727-512-5461
• Email: james@rspine.com
• Phone: 727-512-5461
• Email: james@rspine.com
• Phone: 727-512-5461
• Email: james@rspine.com
• Phone: 727-512-5461
• Email: james@rspine.com
• Phone: 727-512-5461
• Email: james@rspine.com
• Phone: 727-512-5461
• Email: james@rspine.com
• Phone: 727-512-5461
• Email: james@rspine.com
• Phone: 727-512-5461
• Email: james@rspine.com
• Phone: 727-512-5461
• Email: james@rspine.com
• Phone: 888-855-0704
• Email: james@rspine.com
• Phone: 888-855-0704
• Email: james@rspine.com
• Phone: 888-855-0704
• Email: james@rspine.com
• Phone: 888-855-0704
• Email: james@rspine.com
• Phone: 888-855-0704
• Email: james@rspine.com
• Phone: 888-855-0704
• Email: james@rspine.com
• Phone: 888-855-0704
• Email: james@rspine.com
• Phone: 888-855-0704
• Email: james@rspine.com
• Phone: 888-855-0704
• Email: james@rspine.com
• Phone: 888-855-0704
• Email: james@rspine.com
• Phone: 888-855-0704
• Email: james@rspine.com

Device Dimensions

• Width: 9 Millimeter
• Height: 11 Millimeter
• Length: 28 Millimeter
• Width: 9 Millimeter
• Height: 11 Millimeter
• Length: 28 Millimeter
• Width: 9 Millimeter
• Height: 11 Millimeter
• Length: 28 Millimeter
• Width: 9 Millimeter
• Height: 11 Millimeter
• Length: 28 Millimeter
• Width: 9 Millimeter
• Height: 11 Millimeter
• Length: 28 Millimeter
• Width: 9 Millimeter
• Height: 11 Millimeter
• Length: 28 Millimeter
• Width: 9 Millimeter
• Height: 11 Millimeter
• Length: 28 Millimeter
• Width: 9 Millimeter
• Height: 11 Millimeter
• Length: 28 Millimeter
• Width: 9 Millimeter
• Height: 11 Millimeter
• Length: 28 Millimeter
• Width: 9 Millimeter
• Height: 11 Millimeter
• Length: 28 Millimeter
• Width: 9 Millimeter
• Height: 11 Millimeter
• Length: 28 Millimeter
• Width: 9 Millimeter
• Height: 11 Millimeter
• Length: 28 Millimeter
• Width: 9 Millimeter
• Height: 11 Millimeter
• Length: 28 Millimeter
• Width: 9 Millimeter
• Height: 11 Millimeter
• Length: 28 Millimeter
• Width: 9 Millimeter
• Height: 11 Millimeter
• Length: 28 Millimeter
• Width: 9 Millimeter
• Height: 11 Millimeter
• Length: 28 Millimeter
• Width: 9 Millimeter
• Height: 11 Millimeter
• Length: 28 Millimeter
• Width: 9 Millimeter
• Height: 11 Millimeter
• Length: 28 Millimeter
• Width: 9 Millimeter
• Height: 11 Millimeter
• Length: 28 Millimeter
• Width: 9 Millimeter
• Height: 11 Millimeter
• Length: 28 Millimeter
• Width: 9 Millimeter
• Height: 11 Millimeter
• Length: 28 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B07511002228S1106P0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190398

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[B07511002228S1106P0]

Moist Heat or Steam Sterilization

[B07511002228S1106P0]

Moist Heat or Steam Sterilization

[B07511002228S1106P0]

Moist Heat or Steam Sterilization

[B07511002228S1106P0]

Moist Heat or Steam Sterilization

[B07511002228S1106P0]

Moist Heat or Steam Sterilization

[B07511002228S1106P0]

Moist Heat or Steam Sterilization

[B07511002228S1106P0]

Moist Heat or Steam Sterilization

[B07511002228S1106P0]

Moist Heat or Steam Sterilization

[B07511002228S1106P0]

Moist Heat or Steam Sterilization

[B07511002228S1106P0]

Moist Heat or Steam Sterilization

[B07511002228S1106P0]

Moist Heat or Steam Sterilization

[B07511002228S1106P0]

Moist Heat or Steam Sterilization

[B07511002228S1106P0]

Moist Heat or Steam Sterilization

[B07511002228S1106P0]

Moist Heat or Steam Sterilization

[B07511002228S1106P0]

Moist Heat or Steam Sterilization

[B07511002228S1106P0]

Moist Heat or Steam Sterilization

[B07511002228S1106P0]

Moist Heat or Steam Sterilization

[B07511002228S1106P0]

Moist Heat or Steam Sterilization

[B07511002228S1106P0]

Moist Heat or Steam Sterilization

[B07511002228S1106P0]

Moist Heat or Steam Sterilization

[B07511002228S1106P0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-30
• Device Publish Date: 2025-09-22

On-Brand Devices [Restore Interbody Fusion System]

• B07511002228S1106P0: Small Lordotic TLIF Cage - PEEK 28mm(L) x 9mm(W) x 11mm(H) x 6*(A)
• B07511000508MP100: Medium Lordotic Cervical Cage 8mm(H) x 14mm(W) x 12mm(D)