Novel Spinal Spacer System

GUDID 00844856016828

Novel CP, S, 26 mm, PEEK

ALPHATEC SPINE, INC.

Polymeric spinal interbody fusion cage Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis

• Primary Device ID: 00844856016828
• NIH Device Record Key: 1ba7f496-b932-4f6a-836e-fcd44ddc29c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Novel Spinal Spacer System
• Version Model Number: 64733-026
• 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)494-6840
• Email: mfunk@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
• 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: 14 Millimeter
• Length: 14 Millimeter
• Length: 14 Millimeter
• Height: 26 Millimeter
• Width: 18 Millimeter
• Angle: 5 degree
• Length: 20 Millimeter
• Height: 26 Millimeter
• Width: 18 Millimeter
• Angle: 5 degree
• Length: 20 Millimeter
• Height: 26 Millimeter
• Width: 18 Millimeter
• Angle: 5 degree
• Length: 20 Millimeter
• Height: 26 Millimeter
• Width: 18 Millimeter
• Angle: 5 degree
• Length: 20 Millimeter
• Height: 26 Millimeter
• Width: 18 Millimeter
• Angle: 5 degree
• Length: 20 Millimeter
• Height: 26 Millimeter
• Width: 18 Millimeter
• Angle: 5 degree
• Length: 20 Millimeter
• Height: 26 Millimeter
• Width: 18 Millimeter
• Angle: 5 degree
• Length: 20 Millimeter
• Height: 26 Millimeter
• Width: 18 Millimeter
• Angle: 5 degree
• Length: 20 Millimeter
• Height: 26 Millimeter
• Width: 18 Millimeter
• Angle: 5 degree
• Length: 20 Millimeter
• Height: 26 Millimeter
• Width: 18 Millimeter
• Angle: 5 degree
• Length: 20 Millimeter
• Height: 26 Millimeter
• Width: 18 Millimeter
• Angle: 5 degree
• Length: 20 Millimeter
• Height: 26 Millimeter
• Width: 18 Millimeter
• Angle: 5 degree
• Length: 20 Millimeter
• Height: 26 Millimeter
• Width: 18 Millimeter
• Angle: 5 degree
• Length: 20 Millimeter
• Height: 26 Millimeter
• Width: 18 Millimeter
• Angle: 5 degree
• Length: 20 Millimeter
• Height: 26 Millimeter
• Width: 18 Millimeter
• Angle: 5 degree
• Length: 20 Millimeter
• Height: 26 Millimeter
• Width: 18 Millimeter
• Angle: 5 degree
• Length: 20 Millimeter
• Height: 26 Millimeter
• Width: 18 Millimeter
• Angle: 5 degree
• Length: 20 Millimeter
• Height: 26 Millimeter
• Width: 18 Millimeter
• Angle: 5 degree
• Length: 20 Millimeter
• Height: 26 Millimeter
• Width: 18 Millimeter
• Angle: 5 degree
• Length: 20 Millimeter
• Height: 26 Millimeter
• Width: 18 Millimeter
• Angle: 5 degree
• Length: 20 Millimeter
• Height: 26 Millimeter
• Width: 18 Millimeter
• Angle: 5 degree
• Length: 20 Millimeter
• Height: 26 Millimeter
• Width: 18 Millimeter
• Angle: 5 degree
• Length: 20 Millimeter
• Height: 26 Millimeter
• Width: 18 Millimeter
• Angle: 5 degree
• Length: 20 Millimeter
• Height: 26 Millimeter
• Width: 18 Millimeter
• Angle: 5 degree
• Length: 20 Millimeter
• Height: 26 Millimeter
• Width: 18 Millimeter
• Angle: 5 degree
• Length: 20 Millimeter
• Height: 26 Millimeter
• Width: 18 Millimeter
• Angle: 5 degree
• Length: 20 Millimeter
• Height: 26 Millimeter
• Width: 18 Millimeter
• Angle: 5 degree
• Length: 20 Millimeter
• Height: 26 Millimeter
• Width: 18 Millimeter
• Angle: 5 degree
• Length: 20 Millimeter
• Height: 26 Millimeter
• Width: 18 Millimeter
• Angle: 5 degree
• Length: 20 Millimeter
• Height: 26 Millimeter
• Width: 18 Millimeter
• Angle: 5 degree
• Length: 20 Millimeter
• Height: 26 Millimeter
• Width: 18 Millimeter
• Angle: 5 degree
• Length: 20 Millimeter
• Height: 26 Millimeter
• Width: 18 Millimeter
• Angle: 5 degree
• Length: 20 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844856016828 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050553

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

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

[00844856016828]

Moist Heat or Steam Sterilization

[00844856016828]

Moist Heat or Steam Sterilization

[00844856016828]

Moist Heat or Steam Sterilization

[00844856016828]

Moist Heat or Steam Sterilization

[00844856016828]

Moist Heat or Steam Sterilization

[00844856016828]

Moist Heat or Steam Sterilization

[00844856016828]

Moist Heat or Steam Sterilization

[00844856016828]

Moist Heat or Steam Sterilization

[00844856016828]

Moist Heat or Steam Sterilization

[00844856016828]

Moist Heat or Steam Sterilization

[00844856016828]

Moist Heat or Steam Sterilization

[00844856016828]

Moist Heat or Steam Sterilization

[00844856016828]

Moist Heat or Steam Sterilization

[00844856016828]

Moist Heat or Steam Sterilization

[00844856016828]

Moist Heat or Steam Sterilization

[00844856016828]

Moist Heat or Steam Sterilization

[00844856016828]

Moist Heat or Steam Sterilization

[00844856016828]

Moist Heat or Steam Sterilization

[00844856016828]

Moist Heat or Steam Sterilization

[00844856016828]

Moist Heat or Steam Sterilization

[00844856016828]

Moist Heat or Steam Sterilization

[00844856016828]

Moist Heat or Steam Sterilization

[00844856016828]

Moist Heat or Steam Sterilization

[00844856016828]

Moist Heat or Steam Sterilization

[00844856016828]

Moist Heat or Steam Sterilization

[00844856016828]

Moist Heat or Steam Sterilization

[00844856016828]

Moist Heat or Steam Sterilization

[00844856016828]

Moist Heat or Steam Sterilization

[00844856016828]

Moist Heat or Steam Sterilization

[00844856016828]

Moist Heat or Steam Sterilization

[00844856016828]

Moist Heat or Steam Sterilization

[00844856016828]

Moist Heat or Steam Sterilization

[00844856016828]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-08-31

On-Brand Devices [Novel Spinal Spacer System]

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• 00844856066854: Novel SD, Self Distracting PEEK Cage, Wide, Novel, L, 19 mm
• 00844856066847: Novel SD, Self Distracting PEEK Cage, Wide, Novel, L, 18 mm
• 00844856066830: Novel SD, Self Distracting PEEK Cage, Wide, Novel, L, 17 mm
• 00844856066823: Novel SD, Self Distracting PEEK Cage, Wide, Novel, L, 16 mm
• 00844856066816: Novel SD, Self Distracting PEEK Cage, Wide, Novel, L, 8 mm
• 00844856066809: Novel SD, Self Distracting PEEK Cage, Wide, Novel, M, 20 mm
• 00844856066793: Novel SD, Self Distracting PEEK Cage, Wide, Novel, M, 19 mm
• 00844856066786: Novel SD, Self Distracting PEEK Cage, Wide, Novel, M, 18 mm
• 00844856066779: Novel SD, Self Distracting PEEK Cage, Wide, Novel, M, 17 mm
• 00844856066762: Novel SD, Self Distracting PEEK Cage, Wide, Novel, M, 16 mm
• 00844856066755: Novel SD, Self Distracting PEEK Cage, Wide, Novel, M, 8 mm
• 00844856066748: Novel SD, Self Distracting PEEK Cage, Wide, Novel, S, 20 mm
• 00844856066731: Novel SD, Self Distracting PEEK Cage, Wide, Novel, S, 19 mm
• 00844856066724: Novel SD, Self Distracting PEEK Cage, Wide, Novel, S, 18 mm
• 00844856066717: Novel SD, Self Distracting PEEK Cage, Wide, Novel, S, 17 mm
• 00844856066700: Novel SD, Self Distracting PEEK Cage, Wide, Novel, S, 16 mm
• 00844856066694: Novel SD, Self Distracting PEEK Cage, Wide, Novel, S, 15 mm
• 00844856066687: Novel SD, Self Distracting PEEK Cage, Wide, Novel, S, 14 mm
• 00844856066670: Novel SD, Self Distracting PEEK Cage, Wide, Novel, S, 13 mm
• 00844856066663: Novel SD, Self Distracting PEEK Cage, Wide, Novel, S, 12 mm
• 00844856066656: Novel SD, Self Distracting PEEK Cage, Wide, Novel, S, 11 mm
• 00844856066649: Novel SD, Self Distracting PEEK Cage, Wide, Novel, S, 10 mm
• 00844856066632: Novel SD, Self Distracting PEEK Cage, Wide, Novel, S, 9 mm
• 00844856066625: Novel SD, Self Distracting PEEK Cage, Wide, Novel, S, 8 mm
• 00844856066601: Novel SD, Self Distracting PEEK Cage, Novel, Large, 20 mm
• 00844856066588: Novel SD, Self Distracting PEEK Cage, Novel, Large, 19 mm
• 00844856066564: Novel SD, Self Distracting PEEK Cage, Novel, Large, 18 mm
• 00844856066540: Novel SD, Self Distracting PEEK Cage, Novel, Large, 17 mm
• 00844856066526: Novel SD, Large, 16mm, PEEK
• 00844856066427: Self Distracting PEEK Cage, Novel, Medium, 20 mm
• 00844856066403: Self Distracting PEEK Cage, Novel, Medium, 19 mm
• 00844856066380: Self Distracting PEEK Cage, Novel, Medium, 18 mm
• 00844856066366: Self Distracting PEEK Cage, Novel, Medium, 17 mm
• 00844856066342: Novel SD, Medium, 16mm, PEEK
• 00844856066243: Novel SD,Self Distracting PEEK Cage, Novel, Small, 20 mm
• 00844856066229: Novel SD,Self Distracting PEEK Cage, Novel, Small, 19 mm
• 00844856066205: Novel SD,Self Distracting PEEK Cage, Novel, Small, 18 mm
• 00844856066182: Novel SD,Self Distracting PEEK Cage, Novel, Small, 17 mm
• 00844856066168: Novel SD, Small, 16mm, PEEK
• 00844856066076: Novel Cervical Spacer, 12 mm Large, 7deg Lordotic, Titanium
• 00844856066069: Novel Cervical Spacer, 11 mm Large, 7deg Lordotic, Titanium
• 00844856066052: Novel Cervical Spacer, 10 mm Large, 7deg Lordotic, Titanium
• 00844856066045: Novel Cervical Spacer, 9 mm Large, 7deg Lordotic, Titanium
• 00844856066038: Novel Cervical Spacer, 8 mm Large, 7deg Lordotic, Titanium
• 00844856066021: Novel Cervical Spacer, 7 mm Large, 7deg Lordotic, Titanium
• 00844856066014: Novel Cervical Spacer, 6 mm Large, 7deg Lordotic, Titanium
• 00844856066007: Novel Cervical Spacer, 5 mm Large, 7deg Lordotic, Titanium
• 00844856065994: Novel Cervical Spacer, 12 mm Large, 7deg Lordotic, PEEK
• 00844856065987: Novel Cervical Spacer, 11 mm Large, 7deg Lordotic, PEEK