Novel

GUDID 00840967192420

Novel Tapered TL, Large Trial, 5° Lordotic, 9 mm

ALPHATEC SPINE, INC.

Spinal implant trial

• Primary Device ID: 00840967192420
• NIH Device Record Key: d96ed6b6-3ac2-4127-ae49-2708a858c3c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Novel
• Version Model Number: 64679-109
• Company DUNS: 602465783
• Company Name: ALPHATEC SPINE, 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: 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
• 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: 30 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840967192420 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080699

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[00840967192420]

Moist Heat or Steam Sterilization

[00840967192420]

Moist Heat or Steam Sterilization

[00840967192420]

Moist Heat or Steam Sterilization

[00840967192420]

Moist Heat or Steam Sterilization

[00840967192420]

Moist Heat or Steam Sterilization

[00840967192420]

Moist Heat or Steam Sterilization

[00840967192420]

Moist Heat or Steam Sterilization

[00840967192420]

Moist Heat or Steam Sterilization

[00840967192420]

Moist Heat or Steam Sterilization

[00840967192420]

Moist Heat or Steam Sterilization

[00840967192420]

Moist Heat or Steam Sterilization

[00840967192420]

Moist Heat or Steam Sterilization

[00840967192420]

Moist Heat or Steam Sterilization

[00840967192420]

Moist Heat or Steam Sterilization

[00840967192420]

Moist Heat or Steam Sterilization

[00840967192420]

Moist Heat or Steam Sterilization

[00840967192420]

Moist Heat or Steam Sterilization

[00840967192420]

Moist Heat or Steam Sterilization

[00840967192420]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-10
• Device Publish Date: 2020-03-02

On-Brand Devices [Novel]

• 00844856053762: Novel Cervical Trial, 10 mm Large, 7° Lordotic
• 00844856045392: Novel Cervical Trial, 9 mm Large, 7° Lordotic
• 00844856045385: Novel Cervical Trial, 8 mm Large, 7° Lordotic
• 00844856045378: Novel Cervical Trial, 7 mm Large, 7° Lordotic
• 00844856045361: Novel Cervical Trial, 6 mm Large, 7° Lordotic
• 00844856045354: Novel Cervical Trial, 5 mm Large, 7° Lordotic
• 00844856045316: Novel Cervical Trial, 10 mm Small/Medium, 7° Lordotic
• 00844856045309: Novel Cervical Trial, 9 mm Small/Medium, 7° Lordotic
• 00844856045293: Novel Cervical Trial, 8 mm Small/Medium, 7° Lordotic
• 00844856045286: Novel Cervical Trial, 7 mm Small/Medium, 7° Lordotic
• 00844856045279: Novel Cervical Trial, 6 mm Small/Medium, 7° Lordotic
• 00844856045262: Novel Cervical Trial, 5 mm Small/Medium, 7° Lordotic
• 00844856045224: SD Cage Trial Large, 8 mm
• 00844856041271: Novel Posterior Inserter Straight Assembly
• 00844856035348: Novel Lumbar Trial, 18 mm Large, 12° Lordotic
• 00844856035331: Novel Lumbar Trial, 16 mm Large, 12° Lordotic
• 00844856035324: Novel Lumbar Trial, 14 mm Large, 12° Lordotic
• 00844856035317: Novel Lumbar Trial, 12 mm Large, 12° Lordotic
• 00844856035300: Novel Lumbar Trial, 18 mm Large, 7° Lordotic
• 00844856035294: Novel Lumbar Trial, 16 mm Large, 7° Lordotic
• 00844856035287: Novel Lumbar Trial, 14 mm Large, 7° Lordotic
• 00844856035270: Novel Lumbar Trial, 12 mm Large, 7° Lordotic
• 00844856035263: Novel Lumbar Trial, 10 mm Large, 7° Lordotic
• 00844856035256: Novel Lumbar Trial, 18 mm Medium, 12° Lordotic
• 00844856035249: Novel Lumbar Trial, 16 mm Medium, 12° Lordotic
• 00844856035232: Novel Lumbar Trial, 14 mm Medium, 12° Lordotic
• 00844856035225: Novel Lumbar Trial, 12 mm Medium, 12° Lordotic
• 00844856035218: Novel Lumbar Trial, 10 mm Medium, 12° Lordotic
• 00844856035195: Novel Lumbar Trial, 18 mm Medium, 7° Lordotic
• 00844856035188: Novel Lumbar Trial, 16 mm Medium, 7° Lordotic
• 00844856035171: Novel Lumbar Trial, 14 mm Medium, 7° Lordotic
• 00844856035164: Novel Lumbar Trial, 12 mm Medium, 7° Lordotic
• 00844856035157: Novel Lumbar Trial, 10 mm Medium, 7° Lordotic
• 00844856035140: Novel Lumbar Trial, 8 mm Medium, 7° Lordotic
• 00844856035133: Novel Lumbar Trial, 18 mm Small, 12° Lordotic
• 00844856035126: Novel Lumbar Trial, 16 mm Small, 12° Lordotic
• 00844856035119: Novel Lumbar Trial, 14 mm Small, 12° Lordotic
• 00844856035102: Novel Lumbar Trial, 12 mm Small, 12° Lordotic
• 00844856035096: Novel Lumbar Trial, 10 mm Small, 12° Lordotic
• 00844856035089: Novel Lumbar Trial, 8 mm Small, 12° Lordotic
• 00844856035072: Novel Lumbar Trial, 18 mm Small, 7° Lordotic
• 00844856035065: Novel Lumbar Trial, 16 mm Small, 7° Lordotic
• 00844856035058: Novel Lumbar Trial, 14 mm Small, 7° Lordotic
• 00844856035041: Novel Lumbar Trial, 12 mm Small, 7° Lordotic
• 00844856035034: Novel Lumbar Trial, 10 mm Small, 7° Lordotic
• 00844856035027: Novel Lumbar Trial, 8 mm Small, 7° Lordotic
• 00844856034884: Novel Lumbar Inserter Assembly
• 00844856034860: Novel Cervical Rasping Trial 12 mm, L 7° Lordotic
• 00844856034846: Novel Cervical Rasping Trial 11 mm, L 7° Lordotic
• 00844856034822: Novel Cervical Rasping Trial 10 mm, L 7° Lordotic