BB092407A

GUDID 00841379100652

OTLIF SPACER

HYHTE HOLDINGS, INC.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00841379100652
• NIH Device Record Key: b026bad8-8935-4708-8748-803d8926df72
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: BB092407A
• Catalog Number: BB092407A
• 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: 9 Millimeter
• Angle: 0 degree
• Height: 7 Millimeter
• Length: 24 Millimeter
• Width: 9 Millimeter
• Angle: 0 degree
• Height: 7 Millimeter
• Length: 24 Millimeter
• Width: 9 Millimeter
• Angle: 0 degree
• Height: 7 Millimeter
• Length: 24 Millimeter
• Width: 9 Millimeter
• Angle: 0 degree
• Height: 7 Millimeter
• Length: 24 Millimeter
• Width: 9 Millimeter
• Angle: 0 degree
• Height: 7 Millimeter
• Length: 24 Millimeter
• Width: 9 Millimeter
• Angle: 0 degree
• Height: 7 Millimeter
• Length: 24 Millimeter
• Width: 9 Millimeter
• Angle: 0 degree
• Height: 7 Millimeter
• Length: 24 Millimeter
• Width: 9 Millimeter
• Angle: 0 degree
• Height: 7 Millimeter
• Length: 24 Millimeter
• Width: 9 Millimeter
• Angle: 0 degree
• Height: 7 Millimeter
• Length: 24 Millimeter
• Width: 9 Millimeter
• Angle: 0 degree
• Height: 7 Millimeter
• Length: 24 Millimeter
• Width: 9 Millimeter
• Angle: 0 degree
• Height: 7 Millimeter
• Length: 24 Millimeter
• Width: 9 Millimeter
• Angle: 0 degree
• Height: 7 Millimeter
• Length: 24 Millimeter
• Width: 9 Millimeter
• Angle: 0 degree
• Height: 7 Millimeter
• Length: 24 Millimeter
• Width: 9 Millimeter
• Angle: 0 degree
• Height: 7 Millimeter
• Length: 24 Millimeter
• Width: 9 Millimeter
• Angle: 0 degree
• Height: 7 Millimeter
• Length: 24 Millimeter
• Width: 9 Millimeter
• Angle: 0 degree
• Height: 7 Millimeter
• Length: 24 Millimeter
• Width: 9 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841379100652 [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

[00841379100652]

Moist Heat or Steam Sterilization

[00841379100652]

Moist Heat or Steam Sterilization

[00841379100652]

Moist Heat or Steam Sterilization

[00841379100652]

Moist Heat or Steam Sterilization

[00841379100652]

Moist Heat or Steam Sterilization

[00841379100652]

Moist Heat or Steam Sterilization

[00841379100652]

Moist Heat or Steam Sterilization

[00841379100652]

Moist Heat or Steam Sterilization

[00841379100652]

Moist Heat or Steam Sterilization

[00841379100652]

Moist Heat or Steam Sterilization

[00841379100652]

Moist Heat or Steam Sterilization

[00841379100652]

Moist Heat or Steam Sterilization

[00841379100652]

Moist Heat or Steam Sterilization

[00841379100652]

Moist Heat or Steam Sterilization

[00841379100652]

Moist Heat or Steam Sterilization

[00841379100652]

Moist Heat or Steam Sterilization

[00841379100652]

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

Devices Manufactured by HYHTE HOLDINGS, INC.

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• 00840085233326 - NA: 2024-09-11 IMPLANT INSERTER
• 00840085233531 - NA: 2024-09-11 SPACER INSERTER, FORCEPS
• 00840085242458 - NA: 2024-09-11 FULL PLATE INSERTER
• 00840085242472 - NA: 2024-09-11 NAIL INSERTION TOOL
• 00840085268496 - NA: 2024-08-21 SI SCREW, FIXED, COMPRESSION THREAD, ASTURABOND FINISH
• 00840085268502 - NA: 2024-08-21 SI SCREW, FIXED, COMPRESSION THREAD, ASTURABOND FINISH
• 00840085268519 - NA: 2024-08-21 SI SCREW, FIXED, COMPRESSION THREAD, ASTURABOND FINISH