ENDOSKELETON® TL RETRACTOR S06ITM236

GUDID 00191375010067

Dual Cable Light

TITAN SPINE, LLC

Surgical retraction system, reusable

• Primary Device ID: 00191375010067
• NIH Device Record Key: 98644388-af4a-47b0-89c9-8014344bc777
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOSKELETON® TL RETRACTOR
• Version Model Number: S06ITM236
• Catalog Number: S06ITM236
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00191375010067 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K901035

FDA Product Code

• FST: LIGHT, SURGICAL, FIBEROPTIC

Sterilization

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

[00191375010067]

Moist Heat or Steam Sterilization

[00191375010067]

Moist Heat or Steam Sterilization

[00191375010067]

Moist Heat or Steam Sterilization

[00191375010067]

Moist Heat or Steam Sterilization

[00191375010067]

Moist Heat or Steam Sterilization

[00191375010067]

Moist Heat or Steam Sterilization

[00191375010067]

Moist Heat or Steam Sterilization

[00191375010067]

Moist Heat or Steam Sterilization

[00191375010067]

Moist Heat or Steam Sterilization

[00191375010067]

Moist Heat or Steam Sterilization

[00191375010067]

Moist Heat or Steam Sterilization

[00191375010067]

Moist Heat or Steam Sterilization

[00191375010067]

Moist Heat or Steam Sterilization

[00191375010067]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-15

On-Brand Devices [ENDOSKELETON® TL RETRACTOR]

• 00191375010166: Dilator Holder
• 00191375010159: 4th Blade Connector
• 00191375010111: Tray
• 00191375010104: Radial Base for Table Arm
• 00191375010098: Table Arm without Base
• 00191375010081: Dual Extension Cord for Light Mat
• 00191375010074: Reusable Light Connector
• 00191375010067: Dual Cable Light
• 00191375010050: PEEK Dilator #2
• 00191375010043: PEEK Dilator #1
• 00191375010036: Dilator Holder
• 00191375010029: K-wire
• 00191375010012: Wrench
• 00191375010005: Blade Extension, Long
• 00191375009993: Shim and Broach Inserter
• 00191375009986: Broaches
• 00191375009979: Shim
• 00191375009962: 4th Blade, 12x210mm, Titanium
• 00191375009955: 4th Blade, 12x160mm, Titanium
• 00191375009948: 4th Blade Connector
• 00191375009931: Blade Set (Cephalad, Caudal, Posterior), 190mm
• 00191375009924: Blade Set (Cephalad, Caudal, Posterior), 180mm
• 00191375009917: Blade Set (Cephalad, Caudal, Posterior), 170mm
• 00191375009900: Blade Set (Cephalad, Caudal, Posterior), 160mm
• 00191375009894: Blade Set (Cephalad, Caudal, Posterior), 150mm
• 00191375009887: Blade Set (Cephalad, Caudal, Posterior), 140mm
• 00191375009870: Blade Set (Cephalad, Caudal, Posterior), 130mm
• 00191375009863: Blade Set (Cephalad, Caudal, Posterior), 120mm
• 00191375009856: Blade Set (Cephalad, Caudal, Posterior), 110mm
• 00191375009849: Blade Set (Cephalad, Caudal, Posterior), 100mm
• 00191375009832: Blade Set (Cephalad, Caudal, Posterior), 90mm
• 00191375009825: Retractor Body, Aluminum
• 00191375009818: Retractor Body, Steel