Restore Lumbar Interbody Fusion System RETL-28S1306T

GUDID B07511002428S1306T0

Titanium Restore Lumbar Transforaminal Lumbar Lordotic Interbody Cage, 28mm long x 9mm wide x 13mm high x 6°

Republic Spine, LLC

Polymeric spinal interbody fusion cage
Primary Device IDB07511002428S1306T0
NIH Device Record Keycd0dbad3-898f-45e9-9df8-8e165b04180f
Commercial Distribution StatusIn Commercial Distribution
Brand NameRestore Lumbar Interbody Fusion System
Version Model Number110024-28S1306T
Catalog NumberRETL-28S1306T
Company DUNS061891717
Company NameRepublic Spine, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888-855-0704
Emailjames@rspine.com
Phone888-855-0704
Emailjames@rspine.com
Phone888-855-0704
Emailjames@rspine.com
Phone888-855-0704
Emailjames@rspine.com
Phone888-855-0704
Emailjames@rspine.com
Phone888-855-0704
Emailjames@rspine.com
Phone888-855-0704
Emailjames@rspine.com
Phone888-855-0704
Emailjames@rspine.com
Phone888-855-0704
Emailjames@rspine.com
Phone888-855-0704
Emailjames@rspine.com
Phone888-855-0704
Emailjames@rspine.com
Phone888-855-0704
Emailjames@rspine.com
Phone888-855-0704
Emailjames@rspine.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB07511002428S1306T0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B07511002428S1306T0]

Moist Heat or Steam Sterilization


[B07511002428S1306T0]

Moist Heat or Steam Sterilization


[B07511002428S1306T0]

Moist Heat or Steam Sterilization


[B07511002428S1306T0]

Moist Heat or Steam Sterilization


[B07511002428S1306T0]

Moist Heat or Steam Sterilization


[B07511002428S1306T0]

Moist Heat or Steam Sterilization


[B07511002428S1306T0]

Moist Heat or Steam Sterilization


[B07511002428S1306T0]

Moist Heat or Steam Sterilization


[B07511002428S1306T0]

Moist Heat or Steam Sterilization


[B07511002428S1306T0]

Moist Heat or Steam Sterilization


[B07511002428S1306T0]

Moist Heat or Steam Sterilization


[B07511002428S1306T0]

Moist Heat or Steam Sterilization


[B07511002428S1306T0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-01-22
Device Publish Date2026-01-14

On-Brand Devices [Restore Lumbar Interbody Fusion System]

B07511002428S1506T0Titanium Restore Lumbar Transforaminal Lumbar Lordotic Interbody Cage, 28mm long x 9mm wide x 15
B07511002428S1406T0Titanium Restore Lumbar Transforaminal Lumbar Lordotic Interbody Cage, 28mm long x 9mm wide x 14
B07511002428S1306T0Titanium Restore Lumbar Transforaminal Lumbar Lordotic Interbody Cage, 28mm long x 9mm wide x 13
B07511002428S1206T0Titanium Restore Lumbar Transforaminal Lumbar Lordotic Interbody Cage, 28mm long x 9mm wide x 12
B07511002428S1106T0Titanium Restore Lumbar Transforaminal Lumbar Lordotic Interbody Cage, 28mm long x 9mm wide x 11
B07511002428S1006T0Titanium Restore Lumbar Transforaminal Lumbar Lordotic Interbody Cage, 28mm long x 9mm wide x 10
B07511002428S0906T0Titanium Restore Lumbar Transforaminal Lumbar Lordotic Interbody Cage, 28mm long x 9mm wide x 9m
B07511002428S0806T0Titanium Restore Lumbar Transforaminal Lumbar Lordotic Interbody Cage, 28mm long x 9mm wide x 8m
B07511002428S0706T0Titanium Restore Lumbar Transforaminal Lumbar Lordotic Interbody Cage, 28mm long x 9mm wide x 7m
B07511002428S0606T0Titanium Restore Lumbar Transforaminal Lumbar Lordotic Interbody Cage, 28mm long x 9mm wide x 6m

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.