ENDOSKELETON® TL Hyperlordotic 7200-1091

GUDID 00191375045922

ENDOSKELETON® TLh Tamp

TITAN SPINE, LLC

Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable Surgical tamp, reusable

• Primary Device ID: 00191375045922
• NIH Device Record Key: 59d956c8-7b5e-420b-8696-2806cb8a670e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOSKELETON® TL Hyperlordotic
• Version Model Number: 7200-1091
• Catalog Number: 7200-1091
• 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(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
GS1	00191375045922 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191581

FDA Product Code

• OVD: Intervertebral fusion device with integrated fixation, lumbar

Sterilization

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

[00191375045922]

Moist Heat or Steam Sterilization

[00191375045922]

Moist Heat or Steam Sterilization

[00191375045922]

Moist Heat or Steam Sterilization

[00191375045922]

Moist Heat or Steam Sterilization

[00191375045922]

Moist Heat or Steam Sterilization

[00191375045922]

Moist Heat or Steam Sterilization

[00191375045922]

Moist Heat or Steam Sterilization

[00191375045922]

Moist Heat or Steam Sterilization

[00191375045922]

Moist Heat or Steam Sterilization

[00191375045922]

Moist Heat or Steam Sterilization

[00191375045922]

Moist Heat or Steam Sterilization

[00191375045922]

Moist Heat or Steam Sterilization

[00191375045922]

Moist Heat or Steam Sterilization

[00191375045922]

Moist Heat or Steam Sterilization

[00191375045922]

Moist Heat or Steam Sterilization

[00191375045922]

Moist Heat or Steam Sterilization

[00191375045922]

Moist Heat or Steam Sterilization

[00191375045922]

Moist Heat or Steam Sterilization

[00191375045922]

Moist Heat or Steam Sterilization

[00191375045922]

Moist Heat or Steam Sterilization

[00191375045922]

Moist Heat or Steam Sterilization

[00191375045922]

Moist Heat or Steam Sterilization

[00191375045922]

Moist Heat or Steam Sterilization

[00191375045922]

Moist Heat or Steam Sterilization

[00191375045922]

Moist Heat or Steam Sterilization

[00191375045922]

Moist Heat or Steam Sterilization

[00191375045922]

Moist Heat or Steam Sterilization

[00191375045922]

Moist Heat or Steam Sterilization

[00191375045922]

Moist Heat or Steam Sterilization

[00191375045922]

Moist Heat or Steam Sterilization

[00191375045922]

Moist Heat or Steam Sterilization

[00191375045922]

Moist Heat or Steam Sterilization

[00191375045922]

Moist Heat or Steam Sterilization

[00191375045922]

Moist Heat or Steam Sterilization

[00191375045922]

Moist Heat or Steam Sterilization

[00191375045922]

Moist Heat or Steam Sterilization

[00191375045922]

Moist Heat or Steam Sterilization

[00191375045922]

Moist Heat or Steam Sterilization

[00191375045922]

Moist Heat or Steam Sterilization

[00191375045922]

Moist Heat or Steam Sterilization

[00191375045922]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-24
• Device Publish Date: 2020-08-15

On-Brand Devices [ENDOSKELETON® TL Hyperlordotic]

• 00191375050483: ENDOSKELETON® TLh Angled Screwdriver
• 00191375046646: ENDOSKELETON® TLh Grooved Hand-Held Retractor
• 00191375046639: ENDOSKELETON® TLh Straight Screw Driver, No 25 Hexalobe
• 00191375046363: Endoskeleton® TLh Lateral Modular Plate Lock Cover Hex Driver
• 00191375045922: ENDOSKELETON® TLh Tamp
• 00191375045915: ENDOSKELETON® TLh In-Situ Plate Inserter
• 00191375045908: ENDOSKELETON® TLh Integrated Plate Inserter
• 00191375043676: ENDOSKELETON® TLh Plate Screwdriver
• 00191375043669: ENDOSKELETON® TLh Retractable Awl, Angled
• 00191375043652: ENDOSKELETON® TLh Retractable Awl
• 00191375043645: ENDOSKELETON® TLh Plate Inserter Screwdriver
• 00191375043638: ENDOSKELETON® TLh Ligament Cutter
• 00191375042884: 30 Deg Lordotic Trial, 20mm x 26mm
• 00191375042877: 30 Deg Lordotic Trial, 19mm x 26mm
• 00191375042860: 30 Deg Lordotic Trial, 18mm x 26mm
• 00191375042853: 30 Deg Lordotic Trial, 20mm x 22mm
• 00191375042846: 30 Deg Lordotic Trial, 19mm x 22mm
• 00191375042839: 30 Deg Lordotic Trial, 18mm x 22mm
• 00191375042822: 30 Deg Lordotic Trial, 17mm x 22mm
• 00191375042815: 30 Deg Lordotic Trial, 16mm x 22mm
• 00191375042808: 30 Deg Lordotic Trial, 20mm x 18mm
• 00191375042792: 30 Deg Lordotic Trial, 19mm x 18mm
• 00191375042785: 30 Deg Lordotic Trial, 18mm x 18mm
• 00191375042778: 30 Deg Lordotic Trial, 17mm x 18mm
• 00191375042761: 30 Deg Lordotic Trial, 16mm x 18mm
• 00191375042754: 30 Deg Lordotic Trial, 15mm x 18mm
• 00191375042747: 30 Deg Lordotic Trial, 14mm x 18mm
• 00191375042730: 24 Deg Lordotic Trial, 20mm x 26mm
• 00191375042723: 24 Deg Lordotic Trial, 19mm x 26mm
• 00191375042716: 24 Deg Lordotic Trial, 18mm x 26mm
• 00191375042709: 24 Deg Lordotic Trial, 17mm x 26mm
• 00191375042693: 24 Deg Lordotic Trial, 16mm x 26mm
• 00191375042686: 24 Deg Lordotic Trial, 20mm x 22mm
• 00191375042679: 24 Deg Lordotic Trial, 19mm x 22mm
• 00191375042662: 24 Deg Lordotic Trial, 18mm x 22mm
• 00191375042655: 24 Deg Lordotic Trial, 17mm x 22mm
• 00191375042648: 24 Deg Lordotic Trial, 16mm x 22mm
• 00191375042631: 24 Deg Lordotic Trial, 15mm x 22mm
• 00191375042624: 24 Deg Lordotic Trial, 14mm x 22mm
• 00191375042617: 24 Deg Lordotic Trial, 20mm x 18mm
• 00191375042600: 24 Deg Lordotic Trial, 19mm x 18mm
• 00191375042594: 24 Deg Lordotic Trial, 18mm x 18mm
• 00191375042587: 24 Deg Lordotic Trial, 17mm x 18mm
• 00191375042570: 24 Deg Lordotic Trial, 16mm x 18mm
• 00191375042563: 24 Deg Lordotic Trial, 15mm x 18mm
• 00191375042556: 24 Deg Lordotic Trial, 14mm x 18mm
• 00191375042549: 24 Deg Lordotic Trial, 13mm x 18mm
• 00191375042532: 24 Deg Lordotic Trial, 12mm x 18mm
• 00191375042525: 20 Deg Lordotic Trial, 20mm x 26mm
• 00191375042518: 20 Deg Lordotic Trial, 19mm x 26mm