FixxSure®

GUDID M711LS4530

SST, Radel

Innovasis, Inc.

Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver

• Primary Device ID: M711LS4530
• NIH Device Record Key: b524eda4-5ae9-40c5-bd4c-b85795feb6aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FixxSure®
• Version Model Number: LS-453
• Company DUNS: 156567492
• Company Name: Innovasis, Inc.
• 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: 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	M711LS4530 [Primary]

FDA Product Code

• MNH: Orthosis, Spondylolisthesis Spinal Fixation

Sterilization

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

[M711LS4530]

Moist Heat or Steam Sterilization

[M711LS4530]

Moist Heat or Steam Sterilization

[M711LS4530]

Moist Heat or Steam Sterilization

[M711LS4530]

Moist Heat or Steam Sterilization

[M711LS4530]

Moist Heat or Steam Sterilization

[M711LS4530]

Moist Heat or Steam Sterilization

[M711LS4530]

Moist Heat or Steam Sterilization

[M711LS4530]

Moist Heat or Steam Sterilization

[M711LS4530]

Moist Heat or Steam Sterilization

[M711LS4530]

Moist Heat or Steam Sterilization

[M711LS4530]

Moist Heat or Steam Sterilization

[M711LS4530]

Moist Heat or Steam Sterilization

[M711LS4530]

Moist Heat or Steam Sterilization

[M711LS4530]

Moist Heat or Steam Sterilization

[M711LS4530]

Moist Heat or Steam Sterilization

[M711LS4530]

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

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)