Endoskeleton TA 2107-0212

GUDID M682210702120

Interbody Fusion Device 7 Degree Large 12mm

TITAN SPINE, LLC

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage

• Primary Device ID: M682210702120
• NIH Device Record Key: 78a8bf51-0b07-4218-9cb6-afd131c0d1f7
• Commercial Distribution Discontinuation: 2020-09-21
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Endoskeleton TA
• Version Model Number: 2107-0212
• Catalog Number: 2107-0212
• 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
• 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
• 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
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com

Device Dimensions

• Height: 12 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Height: 12 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Width: 36 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M682210702120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080615

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[M682210702120]

Moist Heat or Steam Sterilization

[M682210702120]

Moist Heat or Steam Sterilization

[M682210702120]

Moist Heat or Steam Sterilization

[M682210702120]

Moist Heat or Steam Sterilization

[M682210702120]

Moist Heat or Steam Sterilization

[M682210702120]

Moist Heat or Steam Sterilization

[M682210702120]

Moist Heat or Steam Sterilization

[M682210702120]

Moist Heat or Steam Sterilization

[M682210702120]

Moist Heat or Steam Sterilization

[M682210702120]

Moist Heat or Steam Sterilization

[M682210702120]

Moist Heat or Steam Sterilization

[M682210702120]

Moist Heat or Steam Sterilization

[M682210702120]

Moist Heat or Steam Sterilization

[M682210702120]

Moist Heat or Steam Sterilization

[M682210702120]

Moist Heat or Steam Sterilization

[M682210702120]

Moist Heat or Steam Sterilization

[M682210702120]

Moist Heat or Steam Sterilization

[M682210702120]

Moist Heat or Steam Sterilization

[M682210702120]

Moist Heat or Steam Sterilization

[M682210702120]

Moist Heat or Steam Sterilization

[M682210702120]

Moist Heat or Steam Sterilization

[M682210702120]

Moist Heat or Steam Sterilization

[M682210702120]

Moist Heat or Steam Sterilization

[M682210702120]

Moist Heat or Steam Sterilization

[M682210702120]

Moist Heat or Steam Sterilization

[M682210702120]

Moist Heat or Steam Sterilization

[M682210702120]

Moist Heat or Steam Sterilization

[M682210702120]

Moist Heat or Steam Sterilization

[M682210702120]

Moist Heat or Steam Sterilization

[M682210702120]

Moist Heat or Steam Sterilization

[M682210702120]

Moist Heat or Steam Sterilization

[M682210702120]

Moist Heat or Steam Sterilization

[M682210702120]

Moist Heat or Steam Sterilization

[M682210702120]

Moist Heat or Steam Sterilization

[M682210702120]

Moist Heat or Steam Sterilization

[M682210702120]

Moist Heat or Steam Sterilization

[M682210702120]

Moist Heat or Steam Sterilization

[M682210702120]

Moist Heat or Steam Sterilization

[M682210702120]

Moist Heat or Steam Sterilization

[M682210702120]

Moist Heat or Steam Sterilization

[M682210702120]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-09-22
• Device Publish Date: 2015-09-17

On-Brand Devices [Endoskeleton TA]

• M682210610130: INSERTER
• M682210610060: EXTRACTOR
• M682210610030: THREADED HOLDER
• M682210610010: INSERTER
• M682210610000: IMPACTOR
• M68221070317S0: Interbody Fusion Device 7 Degree X-Large 17mm
• M68221070317N0: Interbody Fusion Device nanoLOCK Surface Technology 7 Degree X-Large 17mm
• M68221070316S0: Interbody Fusion Device 7 Degree X-Large 16mm
• M68221070316N0: Interbody Fusion Device nanoLOCK Surface Technology 7 Degree X-Large 16mm
• M68221070315S0: Interbody Fusion Device 7 Degree X-Large 15mm
• M68221070315N0: Interbody Fusion Device nanoLOCK Surface Technology 7 Degree X-Large 15mm
• M68221070314S0: Interbody Fusion Device 7 Degree X-Large 14mm
• M68221070314N0: Interbody Fusion Device nanoLOCK Surface Technology 7 Degree X-Large 14mm
• M68221070313S0: Interbody Fusion Device 7 Degree X-Large 13mm
• M68221070313N0: Interbody Fusion Device nanoLOCK Surface Technology 7 Degree X-Large 13mm
• M68221070312S0: Interbody Fusion Device 7 Degree X-Large 12mm
• M68221070312N0: Interbody Fusion Device nanoLOCK Surface Technology 7 Degree X-Large 12mm
• M68221070311S0: Interbody Fusion Device 7 Degree X-Large 11mm
• M68221070311N0: Interbody Fusion Device nanoLOCK Surface Technology 7 Degree X-Large 11mm
• M68221070310S0: Interbody Fusion Device 7 Degree X-Large 10mm
• M68221070310N0: Interbody Fusion Device nanoLOCK Surface Technology 7 Degree X-Large 10mm
• M68221070217S0: Interbody Fusion Device 7 Degree Large 17mm
• M68221070217N0: Interbody Fusion Device nanoLOCK Surface Technology 7 Degree Large 17mm
• M68221070216S0: Interbody Fusion Device 7 Degree Large 16mm
• M68221070216N0: Interbody Fusion Device nanoLOCK Surface Technology 7 Degree Large 16mm
• M68221070215S0: Interbody Fusion Device 7 Degree Large 15mm
• M68221070215N0: Interbody Fusion Device nanoLOCK Surface Technology 7 Degree Large 15mm
• M68221070214S0: Interbody Fusion Device 7 Degree Large 14mm
• M68221070214N0: Interbody Fusion Device nanoLOCK Surface Technology 7 Degree Large 14mm
• M68221070213S0: Interbody Fusion Device 7 Degree Large 13mm
• M68221070213N0: Interbody Fusion Device nanoLOCK Surface Technology 7 Degree Large 13mm
• M68221070212S0: Interbody Fusion Device 7 Degree Large 12mm
• M68221070212N0: Interbody Fusion Device nanoLOCK Surface Technology 7 Degree Large 12mm
• M68221070211S0: Interbody Fusion Device 7 Degree Large 11mm
• M68221070211N0: Interbody Fusion Device nanoLOCK Surface Technology 7 Degree Large 11mm
• M68221070210S0: Interbody Fusion Device 7 Degree Large 10mm
• M68221070210N0: Interbody Fusion Device nanoLOCK Surface Technology 7 Degree Large 10mm
• M68221070117S0: Interbody Fusion Device 7 Degree Standard 17mm
• M68221070117N0: Interbody Fusion Device nanoLOCK Surface Technology 7 Degree Standard 17mm
• M68221070116S0: Interbody Fusion Device 7 Degree Standard 16mm
• M68221070116N0: Interbody Fusion Device nanoLOCK Surface Technology 7 Degree Standard 16mm
• M68221070115S0: Interbody Fusion Device 7 Degree Standard 15mm
• M68221070115N0: Interbody Fusion Device nanoLOCK Surface Technology 7 Degree Standard 15mm
• M68221070114S0: Interbody Fusion Device 7 Degree Standard 14mm
• M68221070114N0: Interbody Fusion Device nanoLOCK Surface Technology 7 Degree Standard 14mm
• M68221070113S0: Interbody Fusion Device 7 Degree Standard 13mm
• M68221070113N0: Interbody Fusion Device nanoLOCK Surface Technology 7 Degree Standard 13mm
• M68221070112S0: Interbody Fusion Device 7 Degree Standard 12mm
• M68221070112N0: Interbody Fusion Device nanoLOCK Surface Technology 7 Degree Standard 12mm
• M68221070111S0: Interbody Fusion Device 7 Degree Standard 11mm