CA2000028

GUDID 00841379102472

ACP, 2 LEVEL, 28MM

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

• Primary Device ID: 00841379102472
• NIH Device Record Key: 3f7d1c28-4b0d-4032-bc3e-2c07c4febee2
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: CA2000028
• Catalog Number: CA2000028
• 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: 28 Millimeter
• Device Size Text, specify: 0
• Length: 28 Millimeter
• Device Size Text, specify: 0
• Length: 28 Millimeter
• Device Size Text, specify: 0
• Length: 28 Millimeter
• Device Size Text, specify: 0
• Length: 28 Millimeter
• Device Size Text, specify: 0
• Length: 28 Millimeter
• Device Size Text, specify: 0
• Length: 28 Millimeter
• Device Size Text, specify: 0
• Length: 28 Millimeter
• Device Size Text, specify: 0
• Length: 28 Millimeter
• Device Size Text, specify: 0
• Length: 28 Millimeter
• Device Size Text, specify: 0
• Length: 28 Millimeter
• Device Size Text, specify: 0
• Length: 28 Millimeter
• Device Size Text, specify: 0
• Length: 28 Millimeter
• Device Size Text, specify: 0
• Length: 28 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841379102472 [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

[00841379102472]

Moist Heat or Steam Sterilization

[00841379102472]

Moist Heat or Steam Sterilization

[00841379102472]

Moist Heat or Steam Sterilization

[00841379102472]

Moist Heat or Steam Sterilization

[00841379102472]

Moist Heat or Steam Sterilization

[00841379102472]

Moist Heat or Steam Sterilization

[00841379102472]

Moist Heat or Steam Sterilization

[00841379102472]

Moist Heat or Steam Sterilization

[00841379102472]

Moist Heat or Steam Sterilization

[00841379102472]

Moist Heat or Steam Sterilization

[00841379102472]

Moist Heat or Steam Sterilization

[00841379102472]

Moist Heat or Steam Sterilization

[00841379102472]

Moist Heat or Steam Sterilization

[00841379102472]

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

Devices Manufactured by HYHTE HOLDINGS, INC.

• 00840085254413 - NA: 2024-05-07 POLYAXIAL, TULIP
• 00840085254420 - NA: 2024-05-07 POLYAXIAL, HIGH TOP, TULIP
• 00840085254437 - NA: 2024-05-07 POLYAXIAL, EXTENDED TAB, TULIP
• 00840085254444 - NA: 2024-05-07 FAVORED ANGLE M/L, TULIP
• 00840085254451 - NA: 2024-05-07 FAVORED ANGLE M/L, HIGH TOP, TULIP
• 00840085254468 - NA: 2024-05-07 FAVORED ANGLE M/L, EXTENED TAB, TULIP
• 00840085254475 - NA: 2024-05-07 FAVORED ANGLE C/C, TULIP
• 00840085254482 - NA: 2024-05-07 FAVORED ANGLE C/C, HIGH TOP, TULIP