CA3000063

GUDID 00841379102656

ACP, 3 LEVEL, 63MM

HYHTE HOLDINGS, INC.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00841379102656
• NIH Device Record Key: 06daf807-695e-4232-a589-b1544d85195d
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: CA3000063
• Catalog Number: CA3000063
• 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

Device Dimensions

• Length: 63 Millimeter
• Device Size Text, specify: 0
• Length: 63 Millimeter
• Device Size Text, specify: 0
• Length: 63 Millimeter
• Device Size Text, specify: 0
• Length: 63 Millimeter
• Device Size Text, specify: 0
• Length: 63 Millimeter
• Device Size Text, specify: 0
• Length: 63 Millimeter
• Device Size Text, specify: 0
• Length: 63 Millimeter
• Device Size Text, specify: 0
• Length: 63 Millimeter
• Device Size Text, specify: 0
• Length: 63 Millimeter
• Device Size Text, specify: 0
• Length: 63 Millimeter
• Device Size Text, specify: 0
• Length: 63 Millimeter
• Device Size Text, specify: 0
• Length: 63 Millimeter
• Device Size Text, specify: 0
• Length: 63 Millimeter
• Device Size Text, specify: 0
• Length: 63 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841379102656 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160702

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[00841379102656]

Moist Heat or Steam Sterilization

[00841379102656]

Moist Heat or Steam Sterilization

[00841379102656]

Moist Heat or Steam Sterilization

[00841379102656]

Moist Heat or Steam Sterilization

[00841379102656]

Moist Heat or Steam Sterilization

[00841379102656]

Moist Heat or Steam Sterilization

[00841379102656]

Moist Heat or Steam Sterilization

[00841379102656]

Moist Heat or Steam Sterilization

[00841379102656]

Moist Heat or Steam Sterilization

[00841379102656]

Moist Heat or Steam Sterilization

[00841379102656]

Moist Heat or Steam Sterilization

[00841379102656]

Moist Heat or Steam Sterilization

[00841379102656]

Moist Heat or Steam Sterilization

[00841379102656]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-02

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• 00840085273353 - NA: 2024-11-06 ENDPLATE, 16MM, VARIABLE LORDOSIS, LATERAL, FULL, L.
• 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.