N/A BB092214A

GUDID 00841379100614

OTLIF SPACER, PEEK, 10MMX22MMX14MMX5°, NON-STERILE

HYHTE HOLDINGS, INC.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00841379100614
• NIH Device Record Key: 2a4dfc4d-c382-484d-a66b-417935e99820
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: BB092214A
• Catalog Number: BB092214A
• 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: 14 Millimeter
• Length: 22 Millimeter
• Width: 9 Millimeter
• Angle: 0 degree
• Height: 14 Millimeter
• Length: 22 Millimeter
• Width: 9 Millimeter
• Angle: 0 degree
• Height: 14 Millimeter
• Length: 22 Millimeter
• Width: 9 Millimeter
• Angle: 0 degree
• Height: 14 Millimeter
• Length: 22 Millimeter
• Width: 9 Millimeter
• Angle: 0 degree
• Height: 14 Millimeter
• Length: 22 Millimeter
• Width: 9 Millimeter
• Angle: 0 degree
• Height: 14 Millimeter
• Length: 22 Millimeter
• Width: 9 Millimeter
• Angle: 0 degree
• Height: 14 Millimeter
• Length: 22 Millimeter
• Width: 9 Millimeter
• Angle: 0 degree
• Height: 14 Millimeter
• Length: 22 Millimeter
• Width: 9 Millimeter
• Angle: 0 degree
• Height: 14 Millimeter
• Length: 22 Millimeter
• Width: 9 Millimeter
• Angle: 0 degree
• Height: 14 Millimeter
• Length: 22 Millimeter
• Width: 9 Millimeter
• Angle: 0 degree
• Height: 14 Millimeter
• Length: 22 Millimeter
• Width: 9 Millimeter
• Angle: 0 degree
• Height: 14 Millimeter
• Length: 22 Millimeter
• Width: 9 Millimeter
• Angle: 0 degree
• Height: 14 Millimeter
• Length: 22 Millimeter
• Width: 9 Millimeter
• Angle: 0 degree
• Height: 14 Millimeter
• Length: 22 Millimeter
• Width: 9 Millimeter
• Angle: 0 degree
• Height: 14 Millimeter
• Length: 22 Millimeter
• Width: 9 Millimeter
• Angle: 0 degree
• Height: 14 Millimeter
• Length: 22 Millimeter
• Width: 9 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841379100614 [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

[00841379100614]

Moist Heat or Steam Sterilization

[00841379100614]

Moist Heat or Steam Sterilization

[00841379100614]

Moist Heat or Steam Sterilization

[00841379100614]

Moist Heat or Steam Sterilization

[00841379100614]

Moist Heat or Steam Sterilization

[00841379100614]

Moist Heat or Steam Sterilization

[00841379100614]

Moist Heat or Steam Sterilization

[00841379100614]

Moist Heat or Steam Sterilization

[00841379100614]

Moist Heat or Steam Sterilization

[00841379100614]

Moist Heat or Steam Sterilization

[00841379100614]

Moist Heat or Steam Sterilization

[00841379100614]

Moist Heat or Steam Sterilization

[00841379100614]

Moist Heat or Steam Sterilization

[00841379100614]

Moist Heat or Steam Sterilization

[00841379100614]

Moist Heat or Steam Sterilization

[00841379100614]

Moist Heat or Steam Sterilization

[00841379100614]

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: 2016-11-16

On-Brand Devices [N/A]

• 00841379164388: TLIF SPACER
• 00841379164371: TLIF SPACER
• 00841379164364: TLIF SPACER
• 00841379164357: TLIF SPACER
• 00841379164340: TLIF SPACER
• 00841379164333: TLIF SPACER
• 00841379164326: TLIF SPACER
• 00841379164319: TLIF SPACER
• 00841379164302: TLIF SPACER
• 00841379164296: TLIF SPACER
• 00841379164289: TLIF SPACER
• 00841379164272: TLIF SPACER
• 00841379164265: TLIF SPACER
• 00841379164258: TLIF SPACER
• 00841379164241: TLIF SPACER
• 00841379164234: TLIF SPACER
• 00841379164227: TLIF SPACER
• 00841379164210: TLIF SPACER
• 00841379164203: TLIF SPACER
• 00841379164197: TLIF SPACER
• 00841379164180: TLIF SPACER
• 00841379164173: TLIF SPACER
• 00841379164166: TLIF SPACER
• 00841379164159: TLIF SPACER
• 00841379164142: TLIF SPACER
• 00841379164135: TLIF SPACER
• 00841379164128: TLIF SPACER
• 00841379164111: TLIF SPACER
• 00841379164104: TLIF SPACER
• 00841379164098: TLIF SPACER
• 00841379164081: TLIF SPACER
• 00841379164074: TLIF SPACER
• 00841379164067: TLIF SPACER
• 00841379164050: TLIF SPACER
• 00841379164043: TLIF SPACER
• 00841379164036: TLIF SPACER
• 00841379139898: OTLIF SPACER, PEEK, 10MMX22MMX08MMX5°, NON-STERILE
• 00841379100614: OTLIF SPACER, PEEK, 10MMX22MMX14MMX5°, NON-STERILE
• 00841379100607: OTLIF SPACER, PEEK, 10MMX22MMX13MMX5°, NON-STERILE
• 00841379100584: OTLIF SPACER, PEEK, 10MMX22MMX11MMX5°, NON-STERILE
• 00841379100577: OTLIF SPACER, PEEK, 10MMX22MMX10MMX5°, NON-STERILE
• 00841379100560: OTLIF SPACER, PEEK, 10MMX22MMX09MMX5°, NON-STERILE
• 00841379100553: OTLIF SPACER, PEEK, 10MMX22MMX07MMX5°, NON-STERILE
• 00841379100546: TLIF SPACER
• 00841379100539: TLIF SPACER
• 00841379100522: TLIF SPACER
• 00841379100515: TLIF SPACER
• 00841379100508: TLIF SPACER
• 00841379100492: TLIF SPACER
• 00841379100485: TLIF SPACER