Excella II®

GUDID M711LS1750

Radel, Silicone, SST

Innovasis, Inc.

Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable Surgical torque wrench, reusable

• Primary Device ID: M711LS1750
• NIH Device Record Key: 91c96a09-ed0f-4d62-aa15-2827899c33a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Excella II®
• Version Model Number: LS-175
• Company DUNS: 156567492
• Company Name: Innovasis, Inc.
• 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: false
• Serial Number: true
• 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: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M711LS1750 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102248

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[M711LS1750]

Moist Heat or Steam Sterilization

[M711LS1750]

Moist Heat or Steam Sterilization

[M711LS1750]

Moist Heat or Steam Sterilization

[M711LS1750]

Moist Heat or Steam Sterilization

[M711LS1750]

Moist Heat or Steam Sterilization

[M711LS1750]

Moist Heat or Steam Sterilization

[M711LS1750]

Moist Heat or Steam Sterilization

[M711LS1750]

Moist Heat or Steam Sterilization

[M711LS1750]

Moist Heat or Steam Sterilization

[M711LS1750]

Moist Heat or Steam Sterilization

[M711LS1750]

Moist Heat or Steam Sterilization

[M711LS1750]

Moist Heat or Steam Sterilization

[M711LS1750]

Moist Heat or Steam Sterilization

[M711LS1750]

Moist Heat or Steam Sterilization

[M711LS1750]

Moist Heat or Steam Sterilization

[M711LS1750]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-08
• Device Publish Date: 2022-03-31

On-Brand Devices [Excella II®]

• M711LS1750: Radel, Silicone, SST
• M711LS1600: Al, Silicone, SST
• M711LS1530: SST
• M711LS1470: SST
• M711LS0490: SST
• M711E2S65300: Ti 6Al 4V (ELI)
• M711LS18780: SST
• M711LS18770: SST
• M711LS18760: SST
• M711LS18750: SST
• M711LS1860: SST
• M711LS1690: SST
• M711LS1680: SST
• M711LS1670: SST
• M711LS1660: SST
• M711LS1650: SST
• M711LS1450: SST
• M711LS1440: SST
• M711LS1430: SST
• M711LS1420: SST
• M711LS1410: SST
• M711LA1830: Al, SST, Silicone
• M711LS2070: SST
• M711LS1960: Silicone, SST
• M711LS1910: SST
• M711LS1900: SST
• M711LS1840: Radel
• M711LS1830: Radel
• M711LS1820: SST
• M711LS1590: SST
• M711LS0300: SST
• M711LS0250: SST
• M711LS0120: SST
• M711LS0110: SST
• M711LS0100: SST
• M711LA1530: Silicone, SST
• M711LAT400: Handle, Torque, 40 in-lb., Al, Silicone, SST
• M711LA1840: Universal Ratchet Handle, Custom, Al, SST, Silicone
• M711LS4410: Distractor, 6.0mm, 6mm-66mm, SST, Silicone
• M711LS4400: Compressor, 6mm, 70mm-20mm RAK SIL INSR, SST, Silicone
• M711LS2890: Rod Reducer, SST
• M711LS2200: Awl, Cannulated, Palm Handle, Al, Silicone, SST
• M711LS0510: Bone Awl, w/ Impact Cap, .146 Tip, Al, Silicone, SST