ENDOSKELETON® TT 4214-2514

GUDID 00191375036135

Trial, 4 Deg Lordotic, 14mm

TITAN SPINE, LLC

Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial

• Primary Device ID: 00191375036135
• NIH Device Record Key: accbac03-28b1-4e78-9a7b-629abc2aaac5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOSKELETON® TT
• Version Model Number: 4214-2514
• Catalog Number: 4214-2514
• Company DUNS: 623316978
• Company Name: TITAN SPINE, LLC
• Device Count: 1
• DM Exempt: true
• 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: true
• 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(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com

Device Dimensions

• Height: 14 Millimeter
• Angle: 4 degree
• Device Size Text, specify: 0
• Height: 14 Millimeter
• Angle: 4 degree
• Device Size Text, specify: 0
• Height: 14 Millimeter
• Angle: 4 degree
• Device Size Text, specify: 0
• Height: 14 Millimeter
• Angle: 4 degree
• Device Size Text, specify: 0
• Height: 14 Millimeter
• Angle: 4 degree
• Device Size Text, specify: 0
• Height: 14 Millimeter
• Angle: 4 degree
• Device Size Text, specify: 0
• Height: 14 Millimeter
• Angle: 4 degree
• Device Size Text, specify: 0
• Height: 14 Millimeter
• Angle: 4 degree
• Device Size Text, specify: 0
• Height: 14 Millimeter
• Angle: 4 degree
• Device Size Text, specify: 0
• Height: 14 Millimeter
• Angle: 4 degree
• Device Size Text, specify: 0
• Height: 14 Millimeter
• Angle: 4 degree
• Device Size Text, specify: 0
• Height: 14 Millimeter
• Angle: 4 degree
• Device Size Text, specify: 0
• Height: 14 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00191375036135 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083714

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[00191375036135]

Moist Heat or Steam Sterilization

[00191375036135]

Moist Heat or Steam Sterilization

[00191375036135]

Moist Heat or Steam Sterilization

[00191375036135]

Moist Heat or Steam Sterilization

[00191375036135]

Moist Heat or Steam Sterilization

[00191375036135]

Moist Heat or Steam Sterilization

[00191375036135]

Moist Heat or Steam Sterilization

[00191375036135]

Moist Heat or Steam Sterilization

[00191375036135]

Moist Heat or Steam Sterilization

[00191375036135]

Moist Heat or Steam Sterilization

[00191375036135]

Moist Heat or Steam Sterilization

[00191375036135]

Moist Heat or Steam Sterilization

[00191375036135]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-08
• Device Publish Date: 2019-09-30

On-Brand Devices [ENDOSKELETON® TT]

• 00191375028277: Expandable Distractor
• 00191375028260: Expandable Distractor Tray System
• 00191375003304: Implant Caddy
• 00191375003298: 7mm Caddy
• 00191375003281: TLIF Tray System
• 00191375003274: Surgical Tray System
• 00191375003267: Trial, Parallel, Curved, 7mm
• 00191375003250: Trial, Parallel, Curved, 6mm
• 00191375003243: Trial, 4 Deg Lordotic, Curved, 14mm
• 00191375003236: Trial, 4 Deg Lordotic, Curved, 13mm
• 00191375003229: Trial, 4 Deg Lordotic, Curved, 12mm
• 00191375003212: Trial, 4 Deg Lordotic, Curved, 11mm
• 00191375003205: Trial, 4 Deg Lordotic, Curved, 10mm
• 00191375003199: Trial, 4 Deg Lordotic, Curved, 9mm
• 00191375003182: Trial, 4 Deg Lordotic, Curved, 8mm
• 00191375003168: Shaver, 14mm
• 00191375003151: Shaver, 13mm
• 00191375003144: Shaver, 12mm
• 00191375003137: Shaver, 11mm
• 00191375003120: Shaver, 10mm
• 00191375003113: Shaver, 9mm
• 00191375003106: Shaver, 8mm
• 00191375003090: Shaver, 7mm
• 00191375003083: Hudson, Locking T-Handle
• 00191375003076: Ring Curette, 8mm
• 00191375003069: Large Angled Down Curette
• 00191375003052: Large Angled Left Curette
• 00191375003045: Large Angled Right Curette
• 00191375003038: Large Straight Curette
• 00191375003021: Osteotome
• 00191375003014: Thin Implant Pusher
• 00191375003007: Straight Pusher
• 00191375002994: Curved Implant Holder
• 00191375002987: Implant Holder Assembly, Straight
• 00191375002970: Interbody Fusion Device 4 Degree X-Large 14mm
• 00191375002963: Interbody Fusion Device 4 Degree X-Large 13mm
• 00191375002956: Interbody Fusion Device 4 Degree X-Large 12mm
• 00191375002949: Interbody Fusion Device 4 Degree X-Large 11mm
• 00191375002932: Interbody Fusion Device 4 Degree X-Large 10mm
• 00191375002925: Interbody Fusion Device 4 Degree X-Large 9mm
• 00191375002918: Interbody Fusion Device 4 Degree X-Large 8mm
• 00191375002901: Interbody Fusion Device 4 Degree Large 14mm
• 00191375002895: Interbody Fusion Device 4 Degree Large 13mm
• 00191375002888: Interbody Fusion Device 4 Degree Large 12mm
• 00191375002871: Interbody Fusion Device 4 Degree Large 11mm
• 00191375002864: Interbody Fusion Device 4 Degree Large 10mm
• 00191375002857: Interbody Fusion Device 4 Degree Large 9mm
• 00191375002840: Interbody Fusion Device 4 Degree Large 8mm
• 00191375002833: Interbody Fusion Device 4 Degree Standard 14mm
• 00191375002826: Interbody Fusion Device 4 Degree Standard 13mm