AABA45065

GUDID 00841379108290

POLYAXIAL SCREW, CANNULATED

HYHTE HOLDINGS, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00841379108290
• NIH Device Record Key: eaf4c4d4-d45e-4e18-9c64-55fcfaf92987
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: AABA45065
• Catalog Number: AABA45065
• 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
• 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: 65 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 65 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 65 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841379108290 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153446

FDA Product Code

• MNH: Orthosis, Spondylolisthesis Spinal Fixation

Sterilization

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

[00841379108290]

Moist Heat or Steam Sterilization

[00841379108290]

Moist Heat or Steam Sterilization

[00841379108290]

Moist Heat or Steam Sterilization

[00841379108290]

Moist Heat or Steam Sterilization

[00841379108290]

Moist Heat or Steam Sterilization

[00841379108290]

Moist Heat or Steam Sterilization

[00841379108290]

Moist Heat or Steam Sterilization

[00841379108290]

Moist Heat or Steam Sterilization

[00841379108290]

Moist Heat or Steam Sterilization

[00841379108290]

Moist Heat or Steam Sterilization

[00841379108290]

Moist Heat or Steam Sterilization

[00841379108290]

Moist Heat or Steam Sterilization

[00841379108290]

Moist Heat or Steam Sterilization

[00841379108290]

Moist Heat or Steam Sterilization

[00841379108290]

Moist Heat or Steam Sterilization

[00841379108290]

Moist Heat or Steam Sterilization

[00841379108290]

Moist Heat or Steam Sterilization

[00841379108290]

Moist Heat or Steam Sterilization

[00841379108290]

Moist Heat or Steam Sterilization

[00841379108290]

Moist Heat or Steam Sterilization

[00841379108290]

Moist Heat or Steam Sterilization

[00841379108290]

Moist Heat or Steam Sterilization

[00841379108290]

Moist Heat or Steam Sterilization

[00841379108290]

Moist Heat or Steam Sterilization

[00841379108290]

Moist Heat or Steam Sterilization

[00841379108290]

Moist Heat or Steam Sterilization

[00841379108290]

Moist Heat or Steam Sterilization

[00841379108290]

Moist Heat or Steam Sterilization

[00841379108290]

Moist Heat or Steam Sterilization

[00841379108290]

Moist Heat or Steam Sterilization

[00841379108290]

Moist Heat or Steam Sterilization

[00841379108290]

Moist Heat or Steam Sterilization

[00841379108290]

Moist Heat or Steam Sterilization

[00841379108290]

Moist Heat or Steam Sterilization

[00841379108290]

Moist Heat or Steam Sterilization

[00841379108290]

Moist Heat or Steam Sterilization

[00841379108290]

Moist Heat or Steam Sterilization

[00841379108290]

Moist Heat or Steam Sterilization

[00841379108290]

Moist Heat or Steam Sterilization

[00841379108290]

Moist Heat or Steam Sterilization

[00841379108290]

Moist Heat or Steam Sterilization

[00841379108290]

Moist Heat or Steam Sterilization

[00841379108290]

Moist Heat or Steam Sterilization

[00841379108290]

Moist Heat or Steam Sterilization

[00841379108290]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-02-19

Devices Manufactured by HYHTE HOLDINGS, INC.

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• 00840085271878 - NA: 2025-03-06 EGPS, LUMBAR PEDICLE PROBE, STRAIGHT
• 00840085271885 - NA: 2025-03-06 EGPS, LUMBAR PEDICLE PROBE, CURVED
• 00840085271892 - NA: 2025-03-06 EGPS, THORACIC PEDICLE PROBE, STRAIGHT
• 00840085271908 - NA: 2025-03-06 EGPS, THORACIC PEDICLE PROBE, CURVED
• 00840085271915 - NA: 2025-03-06 EGPS, REAMING PILOT DRILL, 3.5MM
• 00840085271922 - NA: 2025-03-06 EGPS, CORTICAL, TAP, 3.5MM
• 00840085271939 - NA: 2025-03-06 EGPS, CORTICAL, TAP, 4.0MM