T-LIFT

GUDID 00190361023746

T-LIFT INLINE INSERTER SHAFT, T-LIFT

SPINEFRONTIER, INC.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00190361023746
• NIH Device Record Key: 8740d752-2e42-475b-a01f-65b66e9a0fd5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T-LIFT
• Version Model Number: 14-05001
• Company DUNS: 002003243
• Company Name: SPINEFRONTIER, INC.
• 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: 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: +1(978)232-3990
• Email: customerservice@spinefrontier.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190361023746 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111553

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[00190361023746]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-24
• Device Publish Date: 2019-04-05

On-Brand Devices [T-LIFT]

• 00190361023777: SET SCREW, T-LIFT INLINE INSERTER
• 00190361023760: T-LIFT INLINE INSERTER SLEEVE, T-LIFT
• 00190361023753: IMPLANT LOCKING KNOB, T-LIFT
• 00190361023746: T-LIFT INLINE INSERTER SHAFT, T-LIFT
• 00190361023739: SQUARE CONNECT DRIVER SHAFT, T-LIFT
• 00190361023227: SET SCREW, T-LIFT INLINE INSERTER, 14 DEG
• 00190361023210: SQUARE CONNECT DRIVER SHAFT, T-LIFT, 14 DEG
• 00190361023203: INLINE INSERTER SLEEVE, T-LIFT, 14 DEG
• 00190361023197: IMPLANT LOCKING KNOB, T-LIFT, 14 DEG
• 00190361023180: INLINE INSERTER SHAFT, T-LIFT, 14 DEG