ENDOSKELETON TT 4200-1046

GUDID M682420010460

Articulating Inserter, X-Large

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

• Primary Device ID: M682420010460
• NIH Device Record Key: 8e284f4f-eabc-4e94-b32a-72fa21f9ccdd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOSKELETON TT
• Version Model Number: 4200-1046
• Catalog Number: 4200-1046
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M682420010460 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083714

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[M682420010460]

Moist Heat or Steam Sterilization

[M682420010460]

Moist Heat or Steam Sterilization

[M682420010460]

Moist Heat or Steam Sterilization

[M682420010460]

Moist Heat or Steam Sterilization

[M682420010460]

Moist Heat or Steam Sterilization

[M682420010460]

Moist Heat or Steam Sterilization

[M682420010460]

Moist Heat or Steam Sterilization

[M682420010460]

Moist Heat or Steam Sterilization

[M682420010460]

Moist Heat or Steam Sterilization

[M682420010460]

Moist Heat or Steam Sterilization

[M682420010460]

Moist Heat or Steam Sterilization

[M682420010460]

Moist Heat or Steam Sterilization

[M682420010460]

Moist Heat or Steam Sterilization

[M682420010460]

Moist Heat or Steam Sterilization

[M682420010460]

Moist Heat or Steam Sterilization

[M682420010460]

Moist Heat or Steam Sterilization

[M682420010460]

Moist Heat or Steam Sterilization

[M682420010460]

Moist Heat or Steam Sterilization

[M682420010460]

Moist Heat or Steam Sterilization

[M682420010460]

Moist Heat or Steam Sterilization

[M682420010460]

Moist Heat or Steam Sterilization

[M682420010460]

Moist Heat or Steam Sterilization

[M682420010460]

Moist Heat or Steam Sterilization

[M682420010460]

Moist Heat or Steam Sterilization

[M682420010460]

Moist Heat or Steam Sterilization

[M682420010460]

Moist Heat or Steam Sterilization

[M682420010460]

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: 2016-12-08

On-Brand Devices [ENDOSKELETON TT]

• 00191375025719: ARTICULATING INSERTER TRAY SYSTEM
• 00191375025702: Articulating Inserter, X-Large
• M682420010460: Articulating Inserter, X-Large
• M682420010400: CURVED, INSERTER
• M682420010210: THIN, PUSHER
• M682420010030: STRAIGHT, PUSHER
• M682420010010: STRAIGHT, INSERTER
• M682420010190: LARGE, DOWN ANGLED, CURETTE
• M682420010180: LARGE, LEFT ANGLED, CURETTE
• M682420010170: LARGE, RIGHT ANGLED, CURETTE
• M682420010160: LARGE, STRAIGHT, CURETTE
• M682420010100: CONE RING, CURETTE
• M68241143514S0: Interbody Fusion Device 4 Degree X-Large 14mm
• M68241143514N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree X-Large 14mm
• M68241143513S0: Interbody Fusion Device 4 Degree X-Large 13mm
• M68241143513N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree X-Large 13mm
• M68241143512S0: Interbody Fusion Device 4 Degree X-Large 12mm
• M68241143512N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree X-Large 12mm
• M68241143511S0: Interbody Fusion Device 4 Degree X-Large 11mm
• M68241143511N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree X-Large 11mm
• M68241143510S0: Interbody Fusion Device 4 Degree X-Large 10mm
• M68241143510N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree X-Large 10mm
• M68241143509S0: Interbody Fusion Device 4 Degree X-Large 9mm
• M68241143509N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree X-Large 9mm
• M68241143508S0: Interbody Fusion Device 4 Degree X-Large 8mm
• M68241143508N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree X-Large 8mm
• M68241143014S0: Interbody Fusion Device 4 Degree Large 14mm
• M68241143014N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree Large 14mm
• M68241143013S0: Interbody Fusion Device 4 Degree Large 13mm
• M68241143013N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree Large 13mm
• M68241143012S0: Interbody Fusion Device 4 Degree Large 12mm
• M68241143012N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree Large 12mm
• M68241143011S0: Interbody Fusion Device 4 Degree Large 11mm
• M68241143011N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree Large 11mm
• M68241143010S0: Interbody Fusion Device 4 Degree Large 10mm
• M68241143010N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree Large 10mm
• M68241143009S0: Interbody Fusion Device 4 Degree Large 9mm
• M68241143009N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree Large 9mm
• M68241143008S0: Interbody Fusion Device 4 Degree Large 8mm
• M68241143008N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree Large 8mm
• M68241142514S0: Interbody Fusion Device 4 Degree Standard 14mm
• M68241142514N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree Standard 14mm
• M68241142513S0: Interbody Fusion Device 4 Degree Standard 13mm
• M68241142513N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree Standard 13mm
• M68241142512S0: Interbody Fusion Device 4 Degree Standard 12mm
• M68241142512N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree Standard 12mm
• M68241142511S0: Interbody Fusion Device 4 Degree Standard 11mm
• M68241142511N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree Standard 11mm
• M68241142510S0: Interbody Fusion Device 4 Degree Standard 10mm
• M68241142510N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree Standard 10mm