Restore Interbody Fusion REL-01L

GUDID B075110086020

Lumbar Sleek Inserter Body Assembly - Long

Republic Spine, LLC

Orthopaedic inorganic implant inserter/extractor, reusable

• Primary Device ID: B075110086020
• NIH Device Record Key: d2709c09-03bd-4774-9870-ee94769d2668
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Restore Interbody Fusion
• Version Model Number: 110086-02
• Catalog Number: REL-01L
• 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: 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: 561-334-2421
• Email: james@rspine.com
• Phone: 561-334-2421
• Email: james@rspine.com
• Phone: 561-334-2421
• Email: james@rspine.com
• Phone: 561-334-2421
• Email: james@rspine.com
• Phone: 561-334-2421
• Email: james@rspine.com
• Phone: 561-334-2421
• Email: james@rspine.com
• Phone: 561-334-2421
• Email: james@rspine.com
• Phone: 561-334-2421
• Email: james@rspine.com
• Phone: 561-334-2421
• Email: james@rspine.com
• Phone: 561-334-2421
• Email: james@rspine.com
• Phone: 561-334-2421
• Email: james@rspine.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B075110086020 [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

[B075110086020]

Moist Heat or Steam Sterilization

[B075110086020]

Moist Heat or Steam Sterilization

[B075110086020]

Moist Heat or Steam Sterilization

[B075110086020]

Moist Heat or Steam Sterilization

[B075110086020]

Moist Heat or Steam Sterilization

[B075110086020]

Moist Heat or Steam Sterilization

[B075110086020]

Moist Heat or Steam Sterilization

[B075110086020]

Moist Heat or Steam Sterilization

[B075110086020]

Moist Heat or Steam Sterilization

[B075110086020]

Moist Heat or Steam Sterilization

[B075110086020]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-11-26
• Device Publish Date: 2025-11-18

On-Brand Devices [Restore Interbody Fusion]

• B075110104020: Slap Hammer- Large
• B075110104010: Slap Hammer
• B075110089020: Lumbar Sleek Inserter Rod Assembly - Long
• B075110089010: Lumbar Sleek Inserter Rod Assembly - Normal
• B075110086020: Lumbar Sleek Inserter Body Assembly - Long
• B075110086010: Lumbar Sleek Inserter Body Assembly
• B075110083020: Lumbar Tamp - Long
• B075110083010: Lumbar Tamp