ENDOSKELETON® TL RETRACTOR R14154-02-090

GUDID 00191375009832

Blade Set (Cephalad, Caudal, Posterior), 90mm

TITAN SPINE, LLC

Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable

• Primary Device ID: 00191375009832
• NIH Device Record Key: e0abc6b2-8cd5-45ef-a77f-f60ab51a56a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOSKELETON® TL RETRACTOR
• Version Model Number: R14154-02-090
• Catalog Number: R14154-02-090
• Company DUNS: 623316978
• Company Name: TITAN SPINE, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	00191375009832 [Primary]

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

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

[00191375009832]

Moist Heat or Steam Sterilization

[00191375009832]

Moist Heat or Steam Sterilization

[00191375009832]

Moist Heat or Steam Sterilization

[00191375009832]

Moist Heat or Steam Sterilization

[00191375009832]

Moist Heat or Steam Sterilization

[00191375009832]

Moist Heat or Steam Sterilization

[00191375009832]

Moist Heat or Steam Sterilization

[00191375009832]

Moist Heat or Steam Sterilization

[00191375009832]

Moist Heat or Steam Sterilization

[00191375009832]

Moist Heat or Steam Sterilization

[00191375009832]

Moist Heat or Steam Sterilization

[00191375009832]

Moist Heat or Steam Sterilization

[00191375009832]

Moist Heat or Steam Sterilization

[00191375009832]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• 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