Endoskeleton TL 7100-0115-N

GUDID M68271000115N0

Interbody Fusion Device nanoLOCK Surface Technology Parallel 40 (M/L) 18 (A/P) 15 mm

TITAN SPINE, LLC

Metallic spinal interbody fusion cage

• Primary Device ID: M68271000115N0
• NIH Device Record Key: d191c684-aaba-4e7a-8672-4275f10482a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endoskeleton TL
• Version Model Number: 7100-0115-N
• Catalog Number: 7100-0115-N
• 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
• 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

• Device Size Text, specify: 0
• Length: 40 Millimeter
• Width: 18 Millimeter
• Height: 15 Millimeter
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Height: 15 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Width: 18 Millimeter
• Height: 15 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Width: 18 Millimeter
• Height: 15 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Width: 18 Millimeter
• Height: 15 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 40 Millimeter
• Width: 18 Millimeter
• Height: 15 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M68271000115N0 [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