AEJA63R16

GUDID 00841379137689

ROD EXTENSION CONNECTOR, CLOSED

HYHTE HOLDINGS, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00841379137689
• NIH Device Record Key: 9d707030-c673-4309-af02-6d07fad0aecb
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: AEJA63R16
• Catalog Number: AEJA63R16
• 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: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM
• Phone: 7608148047
• Email: PARKER@ASTURAMEDICAL.COM

Device Dimensions

• Width: 6.35 Millimeter
• Length: 300 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Width: 6.35 Millimeter
• Length: 300 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Width: 6.35 Millimeter
• Length: 300 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Width: 6.35 Millimeter
• Length: 300 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Width: 6.35 Millimeter
• Length: 300 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Width: 6.35 Millimeter
• Length: 300 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Width: 6.35 Millimeter
• Length: 300 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Width: 6.35 Millimeter
• Length: 300 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Width: 6.35 Millimeter
• Length: 300 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Width: 6.35 Millimeter
• Length: 300 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Width: 6.35 Millimeter
• Length: 300 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Width: 6.35 Millimeter
• Length: 300 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Width: 6.35 Millimeter
• Length: 300 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Width: 6.35 Millimeter
• Length: 300 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Width: 6.35 Millimeter
• Length: 300 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Width: 6.35 Millimeter
• Length: 300 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Width: 6.35 Millimeter
• Length: 300 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Width: 6.35 Millimeter
• Length: 300 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Width: 6.35 Millimeter
• Length: 300 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Width: 6.35 Millimeter
• Length: 300 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Width: 6.35 Millimeter
• Length: 300 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Width: 6.35 Millimeter
• Length: 300 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Width: 6.35 Millimeter
• Length: 300 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Width: 6.35 Millimeter
• Length: 300 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Width: 6.35 Millimeter
• Length: 300 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Width: 6.35 Millimeter
• Length: 300 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Width: 6.35 Millimeter
• Length: 300 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Width: 6.35 Millimeter
• Length: 300 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Width: 6.35 Millimeter
• Length: 300 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Width: 6.35 Millimeter
• Length: 300 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 6 Millimeter
• Device Size Text, specify: 0
• Width: 6.35 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841379137689 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153446

FDA Product Code

• MNI: Orthosis, Spinal Pedicle Fixation

Sterilization

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

[00841379137689]

Moist Heat or Steam Sterilization

[00841379137689]

Moist Heat or Steam Sterilization

[00841379137689]

Moist Heat or Steam Sterilization

[00841379137689]

Moist Heat or Steam Sterilization

[00841379137689]

Moist Heat or Steam Sterilization

[00841379137689]

Moist Heat or Steam Sterilization

[00841379137689]

Moist Heat or Steam Sterilization

[00841379137689]

Moist Heat or Steam Sterilization

[00841379137689]

Moist Heat or Steam Sterilization

[00841379137689]

Moist Heat or Steam Sterilization

[00841379137689]

Moist Heat or Steam Sterilization

[00841379137689]

Moist Heat or Steam Sterilization

[00841379137689]

Moist Heat or Steam Sterilization

[00841379137689]

Moist Heat or Steam Sterilization

[00841379137689]

Moist Heat or Steam Sterilization

[00841379137689]

Moist Heat or Steam Sterilization

[00841379137689]

Moist Heat or Steam Sterilization

[00841379137689]

Moist Heat or Steam Sterilization

[00841379137689]

Moist Heat or Steam Sterilization

[00841379137689]

Moist Heat or Steam Sterilization

[00841379137689]

Moist Heat or Steam Sterilization

[00841379137689]

Moist Heat or Steam Sterilization

[00841379137689]

Moist Heat or Steam Sterilization

[00841379137689]

Moist Heat or Steam Sterilization

[00841379137689]

Moist Heat or Steam Sterilization

[00841379137689]

Moist Heat or Steam Sterilization

[00841379137689]

Moist Heat or Steam Sterilization

[00841379137689]

Moist Heat or Steam Sterilization

[00841379137689]

Moist Heat or Steam Sterilization

[00841379137689]

Moist Heat or Steam Sterilization

[00841379137689]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-07-16
• Device Publish Date: 2018-06-13

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