RA0000875

GUDID 00840085262074

SI SCREW, MODULAR, STANDARD THREAD, ASTURABOND FINISH

HYHTE HOLDINGS, INC.

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 00840085262074
• NIH Device Record Key: f91a9af3-1367-419e-897c-7caf15ac4bd0
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: RA0000875
• Catalog Number: RA0000875
• Company DUNS: 073029645
• Company Name: HYHTE HOLDINGS, 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: 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: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM

Device Dimensions

• Length: 75 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 75 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 75 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 75 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 75 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 75 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 75 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 75 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 75 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 75 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 75 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 75 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 75 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 75 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 75 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 75 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 75 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 75 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 75 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 75 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 75 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 75 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 75 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 75 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 75 Millimeter
• Outer Diameter: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840085262074 [Primary]

FDA Product Code

• MNH: Orthosis, Spondylolisthesis Spinal Fixation

Sterilization

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

[00840085262074]

Moist Heat or Steam Sterilization

[00840085262074]

Moist Heat or Steam Sterilization

[00840085262074]

Moist Heat or Steam Sterilization

[00840085262074]

Moist Heat or Steam Sterilization

[00840085262074]

Moist Heat or Steam Sterilization

[00840085262074]

Moist Heat or Steam Sterilization

[00840085262074]

Moist Heat or Steam Sterilization

[00840085262074]

Moist Heat or Steam Sterilization

[00840085262074]

Moist Heat or Steam Sterilization

[00840085262074]

Moist Heat or Steam Sterilization

[00840085262074]

Moist Heat or Steam Sterilization

[00840085262074]

Moist Heat or Steam Sterilization

[00840085262074]

Moist Heat or Steam Sterilization

[00840085262074]

Moist Heat or Steam Sterilization

[00840085262074]

Moist Heat or Steam Sterilization

[00840085262074]

Moist Heat or Steam Sterilization

[00840085262074]

Moist Heat or Steam Sterilization

[00840085262074]

Moist Heat or Steam Sterilization

[00840085262074]

Moist Heat or Steam Sterilization

[00840085262074]

Moist Heat or Steam Sterilization

[00840085262074]

Moist Heat or Steam Sterilization

[00840085262074]

Moist Heat or Steam Sterilization

[00840085262074]

Moist Heat or Steam Sterilization

[00840085262074]

Moist Heat or Steam Sterilization

[00840085262074]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-08-13
• Device Publish Date: 2024-02-13

Devices Manufactured by HYHTE HOLDINGS, INC.

• 00841379176572 - NA: 2024-10-11 LRG DIA CORTICAL POLYAXIAL SCREW, EXT TAB, SELF CUTTING
• 00841379176589 - NA: 2024-10-11 LRG DIA CORTICAL POLYAXIAL SCREW, EXT TAB, SELF CUTTING
• 00841379176596 - NA: 2024-10-11 LRG DIA CORTICAL POLYAXIAL SCREW, EXT TAB, SELF CUTTING
• 00841379176602 - NA: 2024-10-11 LRG DIA CORTICAL POLYAXIAL SCREW, EXT TAB, SELF CUTTING
• 00841379176619 - NA: 2024-10-11 LRG DIA CORTICAL POLYAXIAL SCREW, EXT TAB, SELF CUTTING
• 00841379176626 - NA: 2024-10-11 LRG DIA CORTICAL POLYAXIAL SCREW, EXT TAB, SELF CUTTING
• 00841379176633 - NA: 2024-10-11 LRG DIA CORTICAL POLYAXIAL SCREW, EXT TAB, SELF CUTTING
• 00841379176657 - NA: 2024-10-11 LRG DIA CORTICAL POLYAXIAL SCREW, EXT TAB, SELF CUTTING