Alphatec Spine Anterior Lumbar Plating System

GUDID 00844856062955

Aspida, 8mm Sacral Plate

ALPHATEC SPINE, INC.

Orthopaedic fixation plate kit, non-bioabsorbable, sterile

• Primary Device ID: 00844856062955
• NIH Device Record Key: 3e888ea0-5c5e-4fec-a1ac-a6228b7b6024
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alphatec Spine Anterior Lumbar Plating System
• Version Model Number: 51002-08
• Company DUNS: 602465783
• Company Name: ALPHATEC SPINE, INC.
• Device Count: 1
• DM Exempt: true
• 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: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com
• Phone: +1(760)431-9286
• Email: Regulatory@alphatecspine.com

Device Dimensions

• Length: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844856062955 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101255

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[00844856062955]

Moist Heat or Steam Sterilization

[00844856062955]

Moist Heat or Steam Sterilization

[00844856062955]

Moist Heat or Steam Sterilization

[00844856062955]

Moist Heat or Steam Sterilization

[00844856062955]

Moist Heat or Steam Sterilization

[00844856062955]

Moist Heat or Steam Sterilization

[00844856062955]

Moist Heat or Steam Sterilization

[00844856062955]

Moist Heat or Steam Sterilization

[00844856062955]

Moist Heat or Steam Sterilization

[00844856062955]

Moist Heat or Steam Sterilization

[00844856062955]

Moist Heat or Steam Sterilization

[00844856062955]

Moist Heat or Steam Sterilization

[00844856062955]

Moist Heat or Steam Sterilization

[00844856062955]

Moist Heat or Steam Sterilization

[00844856062955]

Moist Heat or Steam Sterilization

[00844856062955]

Moist Heat or Steam Sterilization

[00844856062955]

Moist Heat or Steam Sterilization

[00844856062955]

Moist Heat or Steam Sterilization

[00844856062955]

Moist Heat or Steam Sterilization

[00844856062955]

Moist Heat or Steam Sterilization

[00844856062955]

Moist Heat or Steam Sterilization

[00844856062955]

Moist Heat or Steam Sterilization

[00844856062955]

Moist Heat or Steam Sterilization

[00844856062955]

Moist Heat or Steam Sterilization

[00844856062955]

Moist Heat or Steam Sterilization

[00844856062955]

Moist Heat or Steam Sterilization

[00844856062955]

Moist Heat or Steam Sterilization

[00844856062955]

Moist Heat or Steam Sterilization

[00844856062955]

Moist Heat or Steam Sterilization

[00844856062955]

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: 2015-08-31

On-Brand Devices [Alphatec Spine Anterior Lumbar Plating System]

• 00844856063044: ALIF Screw, 7.0mm x 35mm
• 00844856063037: ALIF Screw, 7.0mm x 25mm
• 00844856063020: ALIF Screw, 6.0mm x 35mm
• 00844856063013: ALIF Screw, 6.0mm x 25mm
• 00844856063006: Aspida, 18mm Sacral Plate
• 00844856062993: Aspida, 16mm Sacral Plate
• 00844856062986: Aspida, 14mm Sacral Plate
• 00844856062979: Aspida, 12mm Sacral Plate
• 00844856062962: Aspida, 10mm Sacral Plate
• 00844856062955: Aspida, 8mm Sacral Plate
• 00844856062948: Aspida, 18mm Lumbar Plate
• 00844856062931: Aspida, 16mm Lumbar Plate
• 00844856062924: Aspida, 14mm Lumbar Plate
• 00844856062917: Aspida, 12mm Lumbar Plate
• 00844856062900: Aspida, 10mm Lumbar Plate
• 00844856062894: Aspida, 8mm Lumbar Plate
• 00844856037021: ALIF Screw, 7.0mm x 30mm
• 00844856036956: ALIF Screw, 6.0mm x 30mm