Alphatec Navigation Instrument

GUDID 00190376018737

4.3 mm Tap, NI

ALPHATEC SPINE, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable

• Primary Device ID: 00190376018737
• NIH Device Record Key: da608ac1-d4cc-40a4-a1e6-af89e9c00db2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alphatec Navigation Instrument
• Version Model Number: 87780-043
• 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: 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: +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: 4.3 Millimeter
• Length: 4.3 Millimeter
• Length: 4.3 Millimeter
• Length: 4.3 Millimeter
• Length: 4.3 Millimeter
• Length: 4.3 Millimeter
• Length: 4.3 Millimeter
• Length: 4.3 Millimeter
• Length: 4.3 Millimeter
• Length: 4.3 Millimeter
• Length: 4.3 Millimeter
• Length: 4.3 Millimeter
• Length: 4.3 Millimeter
• Length: 4.3 Millimeter
• Length: 4.3 Millimeter
• Length: 4.3 Millimeter
• Length: 4.3 Millimeter
• Length: 4.3 Millimeter
• Length: 4.3 Millimeter
• Length: 4.3 Millimeter
• Length: 4.3 Millimeter
• Length: 4.3 Millimeter
• Length: 4.3 Millimeter
• Length: 4.3 Millimeter
• Length: 4.3 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190376018737 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153603
• Premarket Notification: K161363

FDA Product Code

• NKB: Thoracolumbosacral pedicle screw system
• OLO: Orthopedic stereotaxic instrument

Sterilization

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

[00190376018737]

Moist Heat or Steam Sterilization

[00190376018737]

Moist Heat or Steam Sterilization

[00190376018737]

Moist Heat or Steam Sterilization

[00190376018737]

Moist Heat or Steam Sterilization

[00190376018737]

Moist Heat or Steam Sterilization

[00190376018737]

Moist Heat or Steam Sterilization

[00190376018737]

Moist Heat or Steam Sterilization

[00190376018737]

Moist Heat or Steam Sterilization

[00190376018737]

Moist Heat or Steam Sterilization

[00190376018737]

Moist Heat or Steam Sterilization

[00190376018737]

Moist Heat or Steam Sterilization

[00190376018737]

Moist Heat or Steam Sterilization

[00190376018737]

Moist Heat or Steam Sterilization

[00190376018737]

Moist Heat or Steam Sterilization

[00190376018737]

Moist Heat or Steam Sterilization

[00190376018737]

Moist Heat or Steam Sterilization

[00190376018737]

Moist Heat or Steam Sterilization

[00190376018737]

Moist Heat or Steam Sterilization

[00190376018737]

Moist Heat or Steam Sterilization

[00190376018737]

Moist Heat or Steam Sterilization

[00190376018737]

Moist Heat or Steam Sterilization

[00190376018737]

Moist Heat or Steam Sterilization

[00190376018737]

Moist Heat or Steam Sterilization

[00190376018737]

Moist Heat or Steam Sterilization

[00190376018737]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-08-13
• Device Publish Date: 2016-09-14

On-Brand Devices [Alphatec Navigation Instrument]

• 00190376018737: 4.3 mm Tap, NI
• 00190376003689: Cannulated Reduction Polyaxial Screw Driver, NI
• 00190376003337: Cannulated Polyaxial Screw Driver, NI