AAJA65055

GUDID 00841379118183

HIGH TOP POLYAXIAL SCREW, CANNULATED

HYHTE HOLDINGS, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00841379118183
• NIH Device Record Key: 9ebab0bf-468c-493a-b090-a2f639b6face
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: AAJA65055
• Catalog Number: AAJA65055
• 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

Device Dimensions

• Length: 55 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 55 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 55 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841379118183 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153446

FDA Product Code

• MNI: Orthosis, Spinal Pedicle Fixation

Sterilization

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

[00841379118183]

Moist Heat or Steam Sterilization

[00841379118183]

Moist Heat or Steam Sterilization

[00841379118183]

Moist Heat or Steam Sterilization

[00841379118183]

Moist Heat or Steam Sterilization

[00841379118183]

Moist Heat or Steam Sterilization

[00841379118183]

Moist Heat or Steam Sterilization

[00841379118183]

Moist Heat or Steam Sterilization

[00841379118183]

Moist Heat or Steam Sterilization

[00841379118183]

Moist Heat or Steam Sterilization

[00841379118183]

Moist Heat or Steam Sterilization

[00841379118183]

Moist Heat or Steam Sterilization

[00841379118183]

Moist Heat or Steam Sterilization

[00841379118183]

Moist Heat or Steam Sterilization

[00841379118183]

Moist Heat or Steam Sterilization

[00841379118183]

Moist Heat or Steam Sterilization

[00841379118183]

Moist Heat or Steam Sterilization

[00841379118183]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-18

Devices Manufactured by HYHTE HOLDINGS, INC.

• 00840085271861 - NA: 2025-03-06 EGPS, LUMBAR PEDICLE AWL
• 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