BA103012B

GUDID 00841379100386

TLIF SPACER

HYHTE HOLDINGS, INC.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00841379100386
• NIH Device Record Key: d1a5a81a-1ab0-4f38-b26c-6bfa5d8f2409
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: BA103012B
• Catalog Number: BA103012B
• 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: TROY@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: TROY@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: TROY@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: TROY@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: TROY@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: TROY@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: TROY@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: TROY@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: TROY@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: TROY@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: TROY@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: TROY@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: TROY@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: TROY@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: TROY@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: TROY@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: TROY@ASTURAMEDICAL.COM

Device Dimensions

• Width: 10 Millimeter
• Angle: 5 degree
• Height: 12 Millimeter
• Length: 30 Millimeter
• Width: 10 Millimeter
• Angle: 5 degree
• Height: 12 Millimeter
• Length: 30 Millimeter
• Width: 10 Millimeter
• Angle: 5 degree
• Height: 12 Millimeter
• Length: 30 Millimeter
• Width: 10 Millimeter
• Angle: 5 degree
• Height: 12 Millimeter
• Length: 30 Millimeter
• Width: 10 Millimeter
• Angle: 5 degree
• Height: 12 Millimeter
• Length: 30 Millimeter
• Width: 10 Millimeter
• Angle: 5 degree
• Height: 12 Millimeter
• Length: 30 Millimeter
• Width: 10 Millimeter
• Angle: 5 degree
• Height: 12 Millimeter
• Length: 30 Millimeter
• Width: 10 Millimeter
• Angle: 5 degree
• Height: 12 Millimeter
• Length: 30 Millimeter
• Width: 10 Millimeter
• Angle: 5 degree
• Height: 12 Millimeter
• Length: 30 Millimeter
• Width: 10 Millimeter
• Angle: 5 degree
• Height: 12 Millimeter
• Length: 30 Millimeter
• Width: 10 Millimeter
• Angle: 5 degree
• Height: 12 Millimeter
• Length: 30 Millimeter
• Width: 10 Millimeter
• Angle: 5 degree
• Height: 12 Millimeter
• Length: 30 Millimeter
• Width: 10 Millimeter
• Angle: 5 degree
• Height: 12 Millimeter
• Length: 30 Millimeter
• Width: 10 Millimeter
• Angle: 5 degree
• Height: 12 Millimeter
• Length: 30 Millimeter
• Width: 10 Millimeter
• Angle: 5 degree
• Height: 12 Millimeter
• Length: 30 Millimeter
• Width: 10 Millimeter
• Angle: 5 degree
• Height: 12 Millimeter
• Length: 30 Millimeter
• Width: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841379100386 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152512

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00841379100386]

Moist Heat or Steam Sterilization

[00841379100386]

Moist Heat or Steam Sterilization

[00841379100386]

Moist Heat or Steam Sterilization

[00841379100386]

Moist Heat or Steam Sterilization

[00841379100386]

Moist Heat or Steam Sterilization

[00841379100386]

Moist Heat or Steam Sterilization

[00841379100386]

Moist Heat or Steam Sterilization

[00841379100386]

Moist Heat or Steam Sterilization

[00841379100386]

Moist Heat or Steam Sterilization

[00841379100386]

Moist Heat or Steam Sterilization

[00841379100386]

Moist Heat or Steam Sterilization

[00841379100386]

Moist Heat or Steam Sterilization

[00841379100386]

Moist Heat or Steam Sterilization

[00841379100386]

Moist Heat or Steam Sterilization

[00841379100386]

Moist Heat or Steam Sterilization

[00841379100386]

Moist Heat or Steam Sterilization

[00841379100386]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2016-09-09

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• 00840085273360 - NA: 2024-11-06 ENDPLATE, 16MM, VARIABLE LORDOSIS, LATERAL, FULL, L.
• 00840085273377 - NA: 2024-11-06 ENDPLATE, 16MM, VARIABLE LORDOSIS, LATERAL, FULL, L.
• 00840085273384 - NA: 2024-11-06 ENDPLATE, 16MM, VARIABLE LORDOSIS, LATERAL, FULL, L.