FABA35046

GUDID 00841379141426

POLYAXIAL SCREW #1, HIGH TOP

HYHTE HOLDINGS, INC.

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 00841379141426
• NIH Device Record Key: d45d6fe9-0249-4ed3-8e10-6824c7289aa5
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: FABA35046
• Catalog Number: FABA35046
• 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
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM

Device Dimensions

• Width: 3.5 Millimeter
• Length: 46 Millimeter
• Width: 3.5 Millimeter
• Length: 46 Millimeter
• Width: 3.5 Millimeter
• Length: 46 Millimeter
• Width: 3.5 Millimeter
• Length: 46 Millimeter
• Width: 3.5 Millimeter
• Length: 46 Millimeter
• Width: 3.5 Millimeter
• Length: 46 Millimeter
• Width: 3.5 Millimeter
• Length: 46 Millimeter
• Width: 3.5 Millimeter
• Length: 46 Millimeter
• Width: 3.5 Millimeter
• Length: 46 Millimeter
• Width: 3.5 Millimeter
• Length: 46 Millimeter
• Width: 3.5 Millimeter
• Length: 46 Millimeter
• Width: 3.5 Millimeter
• Length: 46 Millimeter
• Width: 3.5 Millimeter
• Length: 46 Millimeter
• Width: 3.5 Millimeter
• Length: 46 Millimeter
• Width: 3.5 Millimeter
• Length: 46 Millimeter
• Width: 3.5 Millimeter
• Length: 46 Millimeter
• Width: 3.5 Millimeter
• Length: 46 Millimeter
• Width: 3.5 Millimeter
• Length: 46 Millimeter
• Width: 3.5 Millimeter
• Length: 46 Millimeter
• Width: 3.5 Millimeter
• Length: 46 Millimeter
• Width: 3.5 Millimeter
• Length: 46 Millimeter
• Width: 3.5 Millimeter
• Length: 46 Millimeter
• Width: 3.5 Millimeter
• Length: 46 Millimeter
• Width: 3.5 Millimeter
• Length: 46 Millimeter
• Width: 3.5 Millimeter
• Length: 46 Millimeter
• Width: 3.5 Millimeter
• Length: 46 Millimeter
• Width: 3.5 Millimeter
• Length: 46 Millimeter
• Width: 3.5 Millimeter
• Length: 46 Millimeter
• Width: 3.5 Millimeter
• Length: 46 Millimeter
• Width: 3.5 Millimeter
• Length: 46 Millimeter
• Width: 3.5 Millimeter
• Length: 46 Millimeter
• Width: 3.5 Millimeter
• Length: 46 Millimeter
• Width: 3.5 Millimeter
• Length: 46 Millimeter
• Width: 3.5 Millimeter
• Length: 46 Millimeter
• Width: 3.5 Millimeter
• Length: 46 Millimeter
• Width: 3.5 Millimeter
• Length: 46 Millimeter
• Width: 3.5 Millimeter
• Length: 46 Millimeter
• Width: 3.5 Millimeter
• Length: 46 Millimeter
• Width: 3.5 Millimeter
• Length: 46 Millimeter
• Width: 3.5 Millimeter
• Length: 46 Millimeter
• Width: 3.5 Millimeter
• Length: 46 Millimeter
• Width: 3.5 Millimeter
• Length: 46 Millimeter
• Width: 3.5 Millimeter
• Length: 46 Millimeter
• Width: 3.5 Millimeter
• Length: 46 Millimeter
• Width: 3.5 Millimeter
• Length: 46 Millimeter
• Width: 3.5 Millimeter
• Length: 46 Millimeter
• Width: 3.5 Millimeter
• Length: 46 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841379141426 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171250

FDA Product Code

• NKG: Posterior Cervical Screw System

Sterilization

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

[00841379141426]

Moist Heat or Steam Sterilization

[00841379141426]

Moist Heat or Steam Sterilization

[00841379141426]

Moist Heat or Steam Sterilization

[00841379141426]

Moist Heat or Steam Sterilization

[00841379141426]

Moist Heat or Steam Sterilization

[00841379141426]

Moist Heat or Steam Sterilization

[00841379141426]

Moist Heat or Steam Sterilization

[00841379141426]

Moist Heat or Steam Sterilization

[00841379141426]

Moist Heat or Steam Sterilization

[00841379141426]

Moist Heat or Steam Sterilization

[00841379141426]

Moist Heat or Steam Sterilization

[00841379141426]

Moist Heat or Steam Sterilization

[00841379141426]

Moist Heat or Steam Sterilization

[00841379141426]

Moist Heat or Steam Sterilization

[00841379141426]

Moist Heat or Steam Sterilization

[00841379141426]

Moist Heat or Steam Sterilization

[00841379141426]

Moist Heat or Steam Sterilization

[00841379141426]

Moist Heat or Steam Sterilization

[00841379141426]

Moist Heat or Steam Sterilization

[00841379141426]

Moist Heat or Steam Sterilization

[00841379141426]

Moist Heat or Steam Sterilization

[00841379141426]

Moist Heat or Steam Sterilization

[00841379141426]

Moist Heat or Steam Sterilization

[00841379141426]

Moist Heat or Steam Sterilization

[00841379141426]

Moist Heat or Steam Sterilization

[00841379141426]

Moist Heat or Steam Sterilization

[00841379141426]

Moist Heat or Steam Sterilization

[00841379141426]

Moist Heat or Steam Sterilization

[00841379141426]

Moist Heat or Steam Sterilization

[00841379141426]

Moist Heat or Steam Sterilization

[00841379141426]

Moist Heat or Steam Sterilization

[00841379141426]

Moist Heat or Steam Sterilization

[00841379141426]

Moist Heat or Steam Sterilization

[00841379141426]

Moist Heat or Steam Sterilization

[00841379141426]

Moist Heat or Steam Sterilization

[00841379141426]

Moist Heat or Steam Sterilization

[00841379141426]

Moist Heat or Steam Sterilization

[00841379141426]

Moist Heat or Steam Sterilization

[00841379141426]

Moist Heat or Steam Sterilization

[00841379141426]

Moist Heat or Steam Sterilization

[00841379141426]

Moist Heat or Steam Sterilization

[00841379141426]

Moist Heat or Steam Sterilization

[00841379141426]

Moist Heat or Steam Sterilization

[00841379141426]

Moist Heat or Steam Sterilization

[00841379141426]

Moist Heat or Steam Sterilization

[00841379141426]

Moist Heat or Steam Sterilization

[00841379141426]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-27
• Device Publish Date: 2021-07-19

Devices Manufactured by HYHTE HOLDINGS, INC.

• 00840085244940 - NA: 2025-01-31 RATCHETING AXIAL HANDLE 2.0 , 1/4 SQ, MIS STYLET ATTACHMENT BACK CAP
• 00840085244957 - NA: 2025-01-31 FAVORED ANGLE C/C, EXTENDED TAB (MIS), EXTENDED THREAD, TULIP
• 00840085244964 - NA: 2025-01-31 FAVORED ANGLE C/C, EXTENDED TAB (MIS), EXTENDED THREAD, TULIP
• 00840085272257 - NA: 2025-01-31 MIS SCREW DRIVER, T27
• 00840085272493 - NA: 2025-01-31 TULIP INSERTER, AXIAL, EXT. TAB
• 00840085274541 - NA: 2025-01-31 TULIP UNLOCKER, EXT. TAB
• 00840085274596 - NA: 2025-01-31 NAVIGATED SCREW DRIVER, MIS T27
• 00840085274671 - NA: 2025-01-31 MIS TOWER SCREW DRIVER, T27