Balteum AL.VT.5533

GUDID 08800039874663

Lumbar Plate Variable screw (Self-Tapping) 5.5 x 33

DIOMEDICAL CO.,LTD.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 08800039874663
• NIH Device Record Key: 86967c5c-1e7d-4e67-acbd-30e9baa532db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Balteum
• Version Model Number: A
• Catalog Number: AL.VT.5533
• Company DUNS: 557795909
• Company Name: DIOMEDICAL CO.,LTD.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com
• Phone: +82313699470
• Email: info@huvexel.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800039874663 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200846

FDA Product Code

• KWQ: Appliance, fixation, spinal intervertebral body

Sterilization

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

[08800039874663]

Moist Heat or Steam Sterilization

[08800039874663]

Moist Heat or Steam Sterilization

[08800039874663]

Moist Heat or Steam Sterilization

[08800039874663]

Moist Heat or Steam Sterilization

[08800039874663]

Moist Heat or Steam Sterilization

[08800039874663]

Moist Heat or Steam Sterilization

[08800039874663]

Moist Heat or Steam Sterilization

[08800039874663]

Moist Heat or Steam Sterilization

[08800039874663]

Moist Heat or Steam Sterilization

[08800039874663]

Moist Heat or Steam Sterilization

[08800039874663]

Moist Heat or Steam Sterilization

[08800039874663]

Moist Heat or Steam Sterilization

[08800039874663]

Moist Heat or Steam Sterilization

[08800039874663]

Moist Heat or Steam Sterilization

[08800039874663]

Moist Heat or Steam Sterilization

[08800039874663]

Moist Heat or Steam Sterilization

[08800039874663]

Moist Heat or Steam Sterilization

[08800039874663]

Moist Heat or Steam Sterilization

[08800039874663]

Moist Heat or Steam Sterilization

[08800039874663]

Moist Heat or Steam Sterilization

[08800039874663]

Moist Heat or Steam Sterilization

[08800039874663]

Moist Heat or Steam Sterilization

[08800039874663]

Moist Heat or Steam Sterilization

[08800039874663]

Moist Heat or Steam Sterilization

[08800039874663]

Moist Heat or Steam Sterilization

[08800039874663]

Moist Heat or Steam Sterilization

[08800039874663]

Moist Heat or Steam Sterilization

[08800039874663]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-13
• Device Publish Date: 2022-12-05

On-Brand Devices [Balteum]

• 08800113999114: Temporary Fixation pin
• 08800039887335: Awl for Drill Guide
• 08800039887328: Awl with Sleeve
• 08800039887311: Variable drill guide (single barrel)
• 08800039887304: Self-retaining Screwdriver T20
• 08800039874984: Lumbar Plate Variable screw (Self-Tapping) 6.5 x 33
• 08800039874960: Lumbar Plate Variable screw (Self-Tapping) 6.5 x 28
• 08800039874946: Lumbar Plate Variable screw (Self-Tapping) 6.5 x 24
• 08800039874922: Lumbar Plate Variable screw (Self-Tapping) 6.5 x 20
• 08800039874663: Lumbar Plate Variable screw (Self-Tapping) 5.5 x 33
• 08800039874649: Lumbar Plate Variable screw (Self-Tapping) 5.5 x 28
• 08800039874625: Lumbar Plate Variable screw (Self-Tapping) 5.5 x 24
• 08800039874601: Lumbar Plate Variable screw (Self-Tapping) 5.5 x 20
• 08800039872423: Lumbar Plate 1level 25
• 08800039872416: Lumbar Plate 1level 23
• 08800039872409: Lumbar Plate 1level 21
• 08800039872393: Lumbar Plate 1level 19
• 08800039872386: Lumbar Plate 1level 17
• 08800039872379: Lumbar Plate 1level 15