GZC10E08C

GUDID 00840085211164

LLIF IMPLANT TRIAL, MODULAR, ANGLED LEFT

HYHTE HOLDINGS, INC.

Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial

• Primary Device ID: 00840085211164
• NIH Device Record Key: c24bd607-890b-4ddb-9a0b-3b468aa3afaf
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: GZC10E08C
• Catalog Number: GZC10E08C
• 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

Device Dimensions

• Width: 26 Millimeter
• Height: 8 Millimeter
• Angle: 12 degree
• Width: 26 Millimeter
• Height: 8 Millimeter
• Angle: 12 degree
• Width: 26 Millimeter
• Height: 8 Millimeter
• Angle: 12 degree
• Width: 26 Millimeter
• Height: 8 Millimeter
• Angle: 12 degree
• Width: 26 Millimeter
• Height: 8 Millimeter
• Angle: 12 degree
• Width: 26 Millimeter
• Height: 8 Millimeter
• Angle: 12 degree
• Width: 26 Millimeter
• Height: 8 Millimeter
• Angle: 12 degree
• Width: 26 Millimeter
• Height: 8 Millimeter
• Angle: 12 degree
• Width: 26 Millimeter
• Height: 8 Millimeter
• Angle: 12 degree
• Width: 26 Millimeter
• Height: 8 Millimeter
• Angle: 12 degree
• Width: 26 Millimeter
• Height: 8 Millimeter
• Angle: 12 degree
• Width: 26 Millimeter
• Height: 8 Millimeter
• Angle: 12 degree
• Width: 26 Millimeter
• Height: 8 Millimeter
• Angle: 12 degree
• Width: 26 Millimeter
• Height: 8 Millimeter
• Angle: 12 degree
• Width: 26 Millimeter
• Height: 8 Millimeter
• Angle: 12 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840085211164 [Primary]

FDA Product Code

• OVD: Intervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

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

[00840085211164]

Moist Heat or Steam Sterilization

[00840085211164]

Moist Heat or Steam Sterilization

[00840085211164]

Moist Heat or Steam Sterilization

[00840085211164]

Moist Heat or Steam Sterilization

[00840085211164]

Moist Heat or Steam Sterilization

[00840085211164]

Moist Heat or Steam Sterilization

[00840085211164]

Moist Heat or Steam Sterilization

[00840085211164]

Moist Heat or Steam Sterilization

[00840085211164]

Moist Heat or Steam Sterilization

[00840085211164]

Moist Heat or Steam Sterilization

[00840085211164]

Moist Heat or Steam Sterilization

[00840085211164]

Moist Heat or Steam Sterilization

[00840085211164]

Moist Heat or Steam Sterilization

[00840085211164]

Moist Heat or Steam Sterilization

[00840085211164]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-22
• Device Publish Date: 2021-07-14

Devices Manufactured by HYHTE HOLDINGS, INC.

• 00840085265167 - NA: 2024-04-22 CORTICAL CANCELLOUS CANNULATED SCREW
• 00840085265174 - NA: 2024-04-22 CORTICAL CANCELLOUS CANNULATED SCREW
• 00840085265181 - NA: 2024-04-22 CORTICAL CANCELLOUS CANNULATED SCREW
• 00840085265198 - NA: 2024-04-22 CORTICAL CANCELLOUS CANNULATED SCREW
• 00840085265204 - NA: 2024-04-22 CORTICAL CANCELLOUS CANNULATED SCREW
• 00840085265211 - NA: 2024-04-22 CORTICAL CANCELLOUS CANNULATED SCREW
• 00840085265228 - NA: 2024-04-22 CORTICAL CANCELLOUS CANNULATED SCREW
• 00840085265235 - NA: 2024-04-22 CORTICAL CANCELLOUS CANNULATED SCREW