LZFSAA08B

GUDID 00840085233678

ZERO PLATE TRIAL

HYHTE HOLDINGS, INC.

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00840085233678
• NIH Device Record Key: 198f71e9-cb61-4761-ad9f-1770949cbf11
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: LZFSAA08B
• Catalog Number: LZFSAA08B
• 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

Device Dimensions

• Width: 14 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Angle: 10 degree
• Width: 14 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Angle: 10 degree
• Width: 14 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Angle: 10 degree
• Width: 14 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Angle: 10 degree
• Width: 14 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Angle: 10 degree
• Width: 14 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Angle: 10 degree
• Width: 14 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Angle: 10 degree
• Width: 14 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Angle: 10 degree
• Width: 14 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Angle: 10 degree
• Width: 14 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Angle: 10 degree
• Width: 14 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Angle: 10 degree
• Width: 14 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Angle: 10 degree
• Width: 14 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Angle: 10 degree
• Width: 14 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Angle: 10 degree
• Width: 14 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Angle: 10 degree
• Width: 14 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Angle: 10 degree
• Width: 14 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Angle: 10 degree
• Width: 14 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Angle: 10 degree
• Width: 14 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Angle: 10 degree
• Width: 14 Millimeter
• Length: 12 Millimeter
• Height: 8 Millimeter
• Angle: 10 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840085233678 [Primary]

FDA Product Code

• OVE: Intervertebral Fusion Device With Integrated Fixation, Cervical

Sterilization

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

[00840085233678]

Moist Heat or Steam Sterilization

[00840085233678]

Moist Heat or Steam Sterilization

[00840085233678]

Moist Heat or Steam Sterilization

[00840085233678]

Moist Heat or Steam Sterilization

[00840085233678]

Moist Heat or Steam Sterilization

[00840085233678]

Moist Heat or Steam Sterilization

[00840085233678]

Moist Heat or Steam Sterilization

[00840085233678]

Moist Heat or Steam Sterilization

[00840085233678]

Moist Heat or Steam Sterilization

[00840085233678]

Moist Heat or Steam Sterilization

[00840085233678]

Moist Heat or Steam Sterilization

[00840085233678]

Moist Heat or Steam Sterilization

[00840085233678]

Moist Heat or Steam Sterilization

[00840085233678]

Moist Heat or Steam Sterilization

[00840085233678]

Moist Heat or Steam Sterilization

[00840085233678]

Moist Heat or Steam Sterilization

[00840085233678]

Moist Heat or Steam Sterilization

[00840085233678]

Moist Heat or Steam Sterilization

[00840085233678]

Moist Heat or Steam Sterilization

[00840085233678]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-04
• Device Publish Date: 2021-07-27

Devices Manufactured by HYHTE HOLDINGS, INC.

• 00840085265488 - NA: 2024-04-25 CORTICAL CANCELLOUS CANNULATED SCREW
• 00840085265495 - NA: 2024-04-25 CORTICAL CANCELLOUS CANNULATED SCREW
• 00840085265501 - NA: 2024-04-25 CORTICAL CANCELLOUS CANNULATED SCREW
• 00840085265518 - NA: 2024-04-25 CORTICAL CANCELLOUS CANNULATED SCREW
• 00840085265525 - NA: 2024-04-25 CORTICAL CANCELLOUS CANNULATED SCREW
• 00840085265532 - NA: 2024-04-25 CORTICAL CANCELLOUS CANNULATED SCREW
• 00840085265549 - NA: 2024-04-25 CORTICAL CANCELLOUS CANNULATED SCREW
• 00840085265556 - NA: 2024-04-25 CORTICAL CANCELLOUS CANNULATED SCREW