ENDOSKELETON TA 2106-1001

GUDID M682210610010

INSERTER

TITAN SPINE, LLC

Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: M682210610010
• NIH Device Record Key: da6f5676-2230-4a17-a06c-9dfb39ad5509
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOSKELETON TA
• Version Model Number: 2106-1001
• Catalog Number: 2106-1001
• Company DUNS: 623316978
• Company Name: TITAN SPINE, LLC
• 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(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 Identifiers

Device Issuing Agency	Device ID
HIBCC	M682210610010 [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

[M682210610010]

Moist Heat or Steam Sterilization

[M682210610010]

Moist Heat or Steam Sterilization

[M682210610010]

Moist Heat or Steam Sterilization

[M682210610010]

Moist Heat or Steam Sterilization

[M682210610010]

Moist Heat or Steam Sterilization

[M682210610010]

Moist Heat or Steam Sterilization

[M682210610010]

Moist Heat or Steam Sterilization

[M682210610010]

Moist Heat or Steam Sterilization

[M682210610010]

Moist Heat or Steam Sterilization

[M682210610010]

Moist Heat or Steam Sterilization

[M682210610010]

Moist Heat or Steam Sterilization

[M682210610010]

Moist Heat or Steam Sterilization

[M682210610010]

Moist Heat or Steam Sterilization

[M682210610010]

Moist Heat or Steam Sterilization

[M682210610010]

Moist Heat or Steam Sterilization

[M682210610010]

Moist Heat or Steam Sterilization

[M682210610010]

Moist Heat or Steam Sterilization

[M682210610010]

Moist Heat or Steam Sterilization

[M682210610010]

Moist Heat or Steam Sterilization

[M682210610010]

Moist Heat or Steam Sterilization

[M682210610010]

Moist Heat or Steam Sterilization

[M682210610010]

Moist Heat or Steam Sterilization

[M682210610010]

Moist Heat or Steam Sterilization

[M682210610010]

Moist Heat or Steam Sterilization

[M682210610010]

Moist Heat or Steam Sterilization

[M682210610010]

Moist Heat or Steam Sterilization

[M682210610010]

Moist Heat or Steam Sterilization

[M682210610010]

Moist Heat or Steam Sterilization

[M682210610010]

Moist Heat or Steam Sterilization

[M682210610010]

Moist Heat or Steam Sterilization

[M682210610010]

Moist Heat or Steam Sterilization

[M682210610010]

Moist Heat or Steam Sterilization

[M682210610010]

Moist Heat or Steam Sterilization

[M682210610010]

Moist Heat or Steam Sterilization

[M682210610010]

Moist Heat or Steam Sterilization

[M682210610010]

Moist Heat or Steam Sterilization

[M682210610010]

Moist Heat or Steam Sterilization

[M682210610010]

Moist Heat or Steam Sterilization

[M682210610010]

Moist Heat or Steam Sterilization

[M682210610010]

Moist Heat or Steam Sterilization

[M682210610010]

Moist Heat or Steam Sterilization

[M682210610010]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-04-23
• Device Publish Date: 2016-09-17

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