FixxSure® 6028

GUDID M71160280

Innovasis, Inc.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: M71160280
• NIH Device Record Key: fa89f6f7-1068-4525-8ba7-9f1471beeb7a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FixxSure®
• Version Model Number: 6028
• Catalog Number: 6028
• Company DUNS: 156567492
• Company Name: Innovasis, Inc.
• 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: true
• 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: 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
• 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

• Length: 28 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 28 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 28 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 28 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 28 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 28 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 28 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 28 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 28 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 28 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 28 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 28 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 28 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 28 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 28 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 28 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 28 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 28 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 28 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 28 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 28 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 28 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 28 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 28 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 28 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 28 Millimeter
• Lumen/Inner Diameter: 6 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M71160280 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081331

FDA Product Code

• MNH: Orthosis, Spondylolisthesis Spinal Fixation

Sterilization

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

[M71160280]

Moist Heat or Steam Sterilization

[M71160280]

Moist Heat or Steam Sterilization

[M71160280]

Moist Heat or Steam Sterilization

[M71160280]

Moist Heat or Steam Sterilization

[M71160280]

Moist Heat or Steam Sterilization

[M71160280]

Moist Heat or Steam Sterilization

[M71160280]

Moist Heat or Steam Sterilization

[M71160280]

Moist Heat or Steam Sterilization

[M71160280]

Moist Heat or Steam Sterilization

[M71160280]

Moist Heat or Steam Sterilization

[M71160280]

Moist Heat or Steam Sterilization

[M71160280]

Moist Heat or Steam Sterilization

[M71160280]

Moist Heat or Steam Sterilization

[M71160280]

Moist Heat or Steam Sterilization

[M71160280]

Moist Heat or Steam Sterilization

[M71160280]

Moist Heat or Steam Sterilization

[M71160280]

Moist Heat or Steam Sterilization

[M71160280]

Moist Heat or Steam Sterilization

[M71160280]

Moist Heat or Steam Sterilization

[M71160280]

Moist Heat or Steam Sterilization

[M71160280]

Moist Heat or Steam Sterilization

[M71160280]

Moist Heat or Steam Sterilization

[M71160280]

Moist Heat or Steam Sterilization

[M71160280]

Moist Heat or Steam Sterilization

[M71160280]

Moist Heat or Steam Sterilization

[M71160280]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-07-23
• Device Publish Date: 2015-04-15

On-Brand Devices [FixxSure®]

• M711LS4530: SST, Radel
• M7116046660: 6046-66
• M7116036460: 6036-46
• M7116031360: 6031-36
• M7116028310: 6028-31
• M71160280: 6028
• M71160270: 6027
• M71160260: 6026
• M71160250: 6025
• M71160240: 6024
• M71160230: 6023
• M7115547660: 5547-66
• M7115546660: 5546-66
• M7115537460: 5537-46
• M7115536460: 5536-46
• M7115531360: 5531-36
• M7115528310: 5528-31
• M71155280: 5528
• M71155270: 5527
• M71155260: 5526
• M71155250: 5525
• M71155240: 5524
• M71155230: 5523