Aspida

GUDID 00190376116006

16mm SACRAL PLATE, TF

ALPHATEC SPINE, 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: 00190376116006
• NIH Device Record Key: df604011-d42b-4489-8509-e6de2ffe9a4d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aspida
• Version Model Number: 51102-16
• 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: false
• 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

Device Dimensions

• Height: 16 Millimeter
• Height: 16 Millimeter
• Height: 16 Millimeter
• Height: 16 Millimeter
• Height: 16 Millimeter
• Height: 16 Millimeter
• Height: 16 Millimeter
• Height: 16 Millimeter
• Height: 16 Millimeter
• Height: 16 Millimeter
• Height: 16 Millimeter
• Height: 16 Millimeter
• Height: 16 Millimeter
• Height: 16 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190376116006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182808

FDA Product Code

• KWQ: Appliance, fixation, spinal intervertebral body

Sterilization

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

[00190376116006]

Moist Heat or Steam Sterilization

[00190376116006]

Moist Heat or Steam Sterilization

[00190376116006]

Moist Heat or Steam Sterilization

[00190376116006]

Moist Heat or Steam Sterilization

[00190376116006]

Moist Heat or Steam Sterilization

[00190376116006]

Moist Heat or Steam Sterilization

[00190376116006]

Moist Heat or Steam Sterilization

[00190376116006]

Moist Heat or Steam Sterilization

[00190376116006]

Moist Heat or Steam Sterilization

[00190376116006]

Moist Heat or Steam Sterilization

[00190376116006]

Moist Heat or Steam Sterilization

[00190376116006]

Moist Heat or Steam Sterilization

[00190376116006]

Moist Heat or Steam Sterilization

[00190376116006]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-01-16
• Device Publish Date: 2019-11-06

On-Brand Devices [Aspida]

• 00840967190846: TEMPORARY FIXATION PIN
• 00190376159645: Medial Temporary Fixation Pin
• 00190376159638: 24MM SACRAL PLATE
• 00190376159621: 22MM SACRAL PLATE
• 00190376159614: 20MM SACRAL PLATE
• 00190376159607: 24MM LUMBAR PLATE
• 00190376159591: 22MM LUMBAR PLATE
• 00190376159584: 20MM LUMBAR PLATE
• 00190376116044: 24mm SACRAL PLATE, TF
• 00190376116037: 22mm SACRAL PLATE, TF
• 00190376116020: 20mm SACRAL PLATE, TF
• 00190376116013: 18mm SACRAL PLATE, TF
• 00190376116006: 16mm SACRAL PLATE, TF
• 00190376115993: 14mm SACRAL PLATE, TF
• 00190376115986: 12mm SACRAL PLATE, TF
• 00190376115979: 10mm SACRAL PLATE, TF
• 00190376115955: 24mm LUMBAR PLATE, TF
• 00190376115948: 22mm LUMBAR PLATE, TF
• 00190376115931: 20mm LUMBAR PLATE, TF
• 00190376115924: 18mm LUMBAR PLATE,TF
• 00190376115917: 16mm LUMBAR PLATE,TF
• 00190376115900: 14mm LUMBAR PLATE, TF
• 00190376115894: 12mm LUMBAR PLATE, TF
• 00190376115887: 10mm LUMBAR PLATE, TF
• 00190376115962: 8mm SACRAL PLATE, TF
• 00190376115870: 8mm LUMBAR PLATE, TF
• 00190376275239: ASPIDA Anterior Lumbar Plate System, TF
• 00190376275222: ASPIDA ANTERIOR LUMBAR PLATE
• 00844856037083: PLATE HOLDER
• 00811801039706: Aspida Plate Holder - Threaded Lock
• 00844856037090: SELF CENTERING AWL
• 00811801038358: Adjustable ASPIDA Awl Guide
• 00811801038341: Adjustable ASPIDA Awl
• 00190376470382: ASPIDA Anterior Lumbar Plate System - Condensed
• 00844856037120: TAP
• 00840967190891: DTS TAP
• 00811801037757: Aspida Temp Tack Driver and Sleeve