Excella Navigation

GUDID M711LS6940

Bone Tap, 4.5mm, Cannulated, MedT Nav, SST

Innovasis, Inc.

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• Primary Device ID: M711LS6940
• NIH Device Record Key: 05ce06af-d77b-4a07-902c-c3eb6b30ec25
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Excella Navigation
• Version Model Number: LS-694
• 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
• Phone: 801-261-2236
• Email: info@innovasis.com

Device Dimensions

• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M711LS6940 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223511

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[M711LS6940]

Moist Heat or Steam Sterilization

[M711LS6940]

Moist Heat or Steam Sterilization

[M711LS6940]

Moist Heat or Steam Sterilization

[M711LS6940]

Moist Heat or Steam Sterilization

[M711LS6940]

Moist Heat or Steam Sterilization

[M711LS6940]

Moist Heat or Steam Sterilization

[M711LS6940]

Moist Heat or Steam Sterilization

[M711LS6940]

Moist Heat or Steam Sterilization

[M711LS6940]

Moist Heat or Steam Sterilization

[M711LS6940]

Moist Heat or Steam Sterilization

[M711LS6940]

Moist Heat or Steam Sterilization

[M711LS6940]

Moist Heat or Steam Sterilization

[M711LS6940]

Moist Heat or Steam Sterilization

[M711LS6940]

Moist Heat or Steam Sterilization

[M711LS6940]

Moist Heat or Steam Sterilization

[M711LS6940]

Moist Heat or Steam Sterilization

[M711LS6940]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-08
• Device Publish Date: 2024-03-31

Devices Manufactured by Innovasis, Inc.

• M711050002045500 - Gibralt®: 2024-04-08 Posterior Cervical Screw Assembly, 4.5mm X 50mm Ti 6Al 4V (ELI)
• M711050002400020 - Gibralt®: 2024-04-08 Posterior Cervical, Set Screw, Rod to Rod Connector, Ti 6Al 4V (ELI)
• M711050002400030 - Gibralt®: 2024-04-08 Posterior Cervical, Set Screw, Reduction Breakoff, Ti 6Al 4V (ELI)
• M711050002500010 - Gibralt®: 2024-04-08 Posterior Cervical, Connector, Nut, Ti 6Al 4V (ELI)
• M711050002640280 - Gibralt®: 2024-04-08 Posterior Cervical Screw Assembly, Smooth, 4.0mm X 28mm, Ti 6Al 4V (ELI)
• M711050002640300 - Gibralt®: 2024-04-08 Posterior Cervical Screw Assembly, Smooth, 4.0mm X 30mm, Ti 6Al 4V (ELI)
• M711050002640320 - Gibralt®: 2024-04-08 Posterior Cervical Screw Assembly, Smooth, 4.0mm X 32mm, Ti 6Al 4V (ELI)
• M711050002640340 - Gibralt®: 2024-04-08 Posterior Cervical Screw Assembly, Smooth, 4.0mm X 34mm, Ti 6Al 4V (ELI)