ENDOSKELETON® TCS 635-041-001

GUDID 00191375050858

13mm Screw Caddy, Lid

TITAN SPINE, LLC

Instrument tray

• Primary Device ID: 00191375050858
• NIH Device Record Key: ed4f9513-4d28-40b0-904a-d6caf11e898d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOSKELETON® TCS
• Version Model Number: 635-041-001
• Catalog Number: 635-041-001
• 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(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Length: 3 Inch
• Device Size Text, specify: 0
• Width: 2.5 Inch
• Length: 3 Inch
• Device Size Text, specify: 0
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• Length: 3 Inch
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Width: 2.5 Inch
• Length: 3 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00191375050858 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151596

FDA Product Code

• LRP: TRAY, SURGICAL
• ODP: Intervertebral fusion device with bone graft, cervical

Sterilization

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

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

[00191375050858]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-11
• Device Publish Date: 2019-11-01

On-Brand Devices [ENDOSKELETON® TCS]

• 00191375027331: Fixed Angle Drill - Driver
• 00191375027324: Fixed Angle Driver, Ancillary Handle
• 00191375025788: 45 Deg, Curved, Retractable Awl
• 00191375025771: Bayonetted Awl Guide, 2.5mm
• 00191375025764: Bayonetted Awl Guide, 2.0mm
• 00191375025757: CURVED, FIXED AWL, 2mm
• 00191375025740: STRAIGHT, FIXED AWL, 2mm
• 00191375011941: Implant Tray System
• 00191375011934: Instrument Rigid Tray System
• 00191375011927: Bone Screw Extractor
• 00191375011910: Torque Limiting Handle
• 00191375011903: U-Joint, Drill
• 00191375011897: No 8 Hexalobe, U-Joint Driver
• 00191375011880: U-Joint, Awl
• 00191375011873: Inserter
• 00191375011866: Awl Guide
• 00191375011859: Swivel Driver, No 8 Hexalobe
• 00191375011842: No 8 Hexalobe, Straight Driver
• 00191375011835: Curved, Fixed Awl
• 00191375011828: Straight, Fixed Awl
• 00191375011811: Mallet
• 00191375011804: Ratcheting Handle
• 00191375011798: Retractable Straight Awl, Straight
• 00191375011781: Rongeur
• 00191375011774: Slap Hammer
• 00191375011767: Trial, 6 Deg Lordotic, Large, 11mm
• 00191375011750: Trial, 6 Deg Lordotic, Large, 9mm
• 00191375011743: Trial, 6 Deg Lordotic, Large, 7mm
• 00191375011736: Trial, 6 Deg Lordotic, Large, 5mm
• 00191375011729: Trial, 6 Deg Lordotic, Medium, 11mm
• 00191375011712: Trial, 6 Deg Lordotic, Medium, 9mm
• 00191375011705: Trial, 6 Deg Lordotic, Medium, 7mm
• 00191375011699: Trial, 6 Deg Lordotic, Medium, 5mm
• 00191375011682: Trial, 6 Deg Lordotic, Small, 11mm
• 00191375011675: Trial, 6 Deg Lordotic, Small, 9mm
• 00191375011668: Trial, 6 Deg Lordotic, Small, 7mm
• 00191375011651: Trial, 6 Deg Lordotic, Small, 5mm
• 00191375011644: Bone Screw, Locking, 3.8mm x 20mm
• 00191375011637: Bone Screw, Locking, 3.8mm x 19mm
• 00191375011620: Bone Screw, Locking, 3.8mm x 18mm
• 00191375011613: Bone Screw, Locking, 3.8mm x 17mm
• 00191375011606: Bone Screw, Locking, 3.8mm x 16mm
• 00191375011590: Bone Screw, Locking, 3.8mm x 15mm
• 00191375011583: Bone Screw, Locking, 3.8mm x 14mm
• 00191375011576: Bone Screw, Locking, 3.8mm x 13mm
• 00191375011569: Bone Screw, Locking, 3.5mm x 20mm
• 00191375011552: Bone Screw, Locking, 3.5mm x 19mm
• 00191375011545: Bone Screw, Locking, 3.5mm x 18mm
• 00191375011538: Bone Screw, Locking, 3.5mm x 17mm
• 00191375011521: Bone Screw, Locking, 3.5mm x 16mm