AAHA50025

GUDID 00841379115694

HIGH TOP POLYAXIAL SCREW

HYHTE HOLDINGS, INC.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00841379115694
• NIH Device Record Key: 4bae5eaa-d1e0-44df-a151-8372fb6313c2
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: AAHA50025
• Catalog Number: AAHA50025
• 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

• Outer Diameter: 5 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841379115694 [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

[00841379115694]

Moist Heat or Steam Sterilization

[00841379115694]

Moist Heat or Steam Sterilization

[00841379115694]

Moist Heat or Steam Sterilization

[00841379115694]

Moist Heat or Steam Sterilization

[00841379115694]

Moist Heat or Steam Sterilization

[00841379115694]

Moist Heat or Steam Sterilization

[00841379115694]

Moist Heat or Steam Sterilization

[00841379115694]

Moist Heat or Steam Sterilization

[00841379115694]

Moist Heat or Steam Sterilization

[00841379115694]

Moist Heat or Steam Sterilization

[00841379115694]

Moist Heat or Steam Sterilization

[00841379115694]

Moist Heat or Steam Sterilization

[00841379115694]

Moist Heat or Steam Sterilization

[00841379115694]

Moist Heat or Steam Sterilization

[00841379115694]

Moist Heat or Steam Sterilization

[00841379115694]

Moist Heat or Steam Sterilization

[00841379115694]

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: 2018-04-13

Devices Manufactured by HYHTE HOLDINGS, INC.

• 00840085254413 - NA: 2024-05-07 POLYAXIAL, TULIP
• 00840085254420 - NA: 2024-05-07 POLYAXIAL, HIGH TOP, TULIP
• 00840085254437 - NA: 2024-05-07 POLYAXIAL, EXTENDED TAB, TULIP
• 00840085254444 - NA: 2024-05-07 FAVORED ANGLE M/L, TULIP
• 00840085254451 - NA: 2024-05-07 FAVORED ANGLE M/L, HIGH TOP, TULIP
• 00840085254468 - NA: 2024-05-07 FAVORED ANGLE M/L, EXTENED TAB, TULIP
• 00840085254475 - NA: 2024-05-07 FAVORED ANGLE C/C, TULIP
• 00840085254482 - NA: 2024-05-07 FAVORED ANGLE C/C, HIGH TOP, TULIP