Endoskeleton TL 7112-0211-S

GUDID M68271120211S0

Interbody Fusion Device 12 Degree 45 (M/L) 18 (A/P) 11 mm

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 Metallic spinal interbody fusion cage

• Primary Device ID: M68271120211S0
• NIH Device Record Key: 3f64d778-2bf5-435f-8c14-ac43c02e496c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endoskeleton TL
• Version Model Number: 7112-0211-S
• Catalog Number: 7112-0211-S
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com

Device Dimensions

• Length: 45 Millimeter
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Angle: 12 degree

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M68271120211S0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140055

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-09-17

On-Brand Devices [Endoskeleton TL]

• M682720011220: 22MM IMPLANT INSERTER
• M682720011180: 18MM IMPLANT INSERTER
• M682720010120: SLIDE, 12MM
• M682720010110: IMPACTOR
• M682720010040: THREADED INSERTER
• M682720080000: 90 DEG ANGLED, DOWN, MEDIUM, CUP CURETTE
• M682720010640: STRAIGHT, RING CURETTE
• M682720010320: LARGE, UP, CUP CURETTE
• M682720010270: ROTATE CUTTER, 10MM
• M682720010260: LARGE, STRAIGHT, CUP CURETTE
• M682720010250: MEDIUM, DOWN, CUP CURETTE
• M682720010240: MEDIUM, UP, CUP CURETTE
• M682720010230: MEDIUM, STRAIGHT, CUP CURETTE
• M682720010220: SMALL, DOWN, CUP CURETTE
• M682720010210: SMALL, UP, CUP CURETTE
• M682720010200: SMALL, STRAIGHT, CUP CURETTE
• M682720010190: ROTATE CUTTER, 8MM
• M682720010180: ANGLED, FIXED, RING CURETTE
• M68271122516S0: Interbody Fusion Device 12 Degree 60 (M/L) 26 (A/P) 16 mm
• M68271122516N0: Interbody Fusion Device nanoLOCK Surface Technology 12 Degree 60 (M/L) 26 (A/P) 16 mm
• M68271122515S0: Interbody Fusion Device 12 Degree 60 (M/L) 26 (A/P) 15 mm
• M68271122515N0: Interbody Fusion Device nanoLOCK Surface Technology 12 Degree 60 (M/L) 26 (A/P) 15 mm
• M68271122514S0: Interbody Fusion Device 12 Degree 60 (M/L) 26 (A/P) 14 mm
• M68271122514N0: Interbody Fusion Device nanoLOCK Surface Technology 12 Degree 60 (M/L) 26 (A/P) 14 mm
• M68271122513S0: Interbody Fusion Device 12 Degree 60 (M/L) 26 (A/P) 13 mm
• M68271122513N0: Interbody Fusion Device nanoLOCK Surface Technology 12 Degree 60 (M/L) 26 (A/P) 13 mm
• M68271122512S0: Interbody Fusion Device 12 Degree 60 (M/L) 26 (A/P) 12 mm
• M68271122512N0: Interbody Fusion Device nanoLOCK Surface Technology 12 Degree 60 (M/L) 26 (A/P) 12 mm
• M68271122511S0: Interbody Fusion Device 12 Degree 60 (M/L) 26 (A/P) 11 mm
• M68271122511N0: Interbody Fusion Device nanoLOCK Surface Technology 12 Degree 60 (M/L) 26 (A/P) 11 mm
• M68271122510S0: Interbody Fusion Device 12 Degree 60 (M/L) 26 (A/P) 10 mm
• M68271122510N0: Interbody Fusion Device nanoLOCK Surface Technology 12 Degree 60 (M/L) 26 (A/P) 10 mm
• M68271122509S0: Interbody Fusion Device 12 Degree 60 (M/L) 26 (A/P) 9 mm
• M68271122509N0: Interbody Fusion Device nanoLOCK Surface Technology 12 Degree 60 (M/L) 26 (A/P) 9 mm
• M68271122508S0: Interbody Fusion Device 12 Degree 60 (M/L) 26 (A/P) 8 mm
• M68271122508N0: Interbody Fusion Device nanoLOCK Surface Technology 12 Degree 60 (M/L) 26 (A/P) 8 mm
• M68271122416S0: Interbody Fusion Device 12 Degree 55 (M/L) 26 (A/P) 16 mm
• M68271122416N0: Interbody Fusion Device nanoLOCK Surface Technology 12 Degree 55 (M/L) 26 (A/P) 16 mm
• M68271122415S0: Interbody Fusion Device 12 Degree 55 (M/L) 26 (A/P) 15 mm
• M68271122415N0: Interbody Fusion Device nanoLOCK Surface Technology 12 Degree 55 (M/L) 26 (A/P) 15 mm
• M68271122414S0: Interbody Fusion Device 12 Degree 55 (M/L) 26 (A/P) 14 mm
• M68271122414N0: Interbody Fusion Device nanoLOCK Surface Technology 12 Degree 55 (M/L) 26 (A/P) 14 mm
• M68271122413S0: Interbody Fusion Device 12 Degree 55 (M/L) 26 (A/P) 13 mm
• M68271122413N0: Interbody Fusion Device nanoLOCK Surface Technology 12 Degree 55 (M/L) 26 (A/P) 13 mm
• M68271122412S0: Interbody Fusion Device 12 Degree 55 (M/L) 26 (A/P) 12 mm
• M68271122412N0: Interbody Fusion Device nanoLOCK Surface Technology 12 Degree 55 (M/L) 26 (A/P) 12 mm
• M68271122411S0: Interbody Fusion Device 12 Degree 55 (M/L) 26 (A/P) 11 mm
• M68271122411N0: Interbody Fusion Device nanoLOCK Surface Technology 12 Degree 55 (M/L) 26 (A/P) 11 mm
• M68271122410S0: Interbody Fusion Device 12 Degree 55 (M/L) 26 (A/P) 10 mm
• M68271122410N0: Interbody Fusion Device nanoLOCK Surface Technology 12 Degree 55 (M/L) 26 (A/P) 10 mm