Novel Spinal Spacer System

GUDID 00844856008908

Novel LCC PEEK, 25M, 8mm

ALPHATEC SPINE, INC.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00844856008908
• NIH Device Record Key: 62b296cc-625b-41db-ad83-84a30e258737
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Novel Spinal Spacer System
• Version Model Number: 64115-008
• 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

• Height: 8 Millimeter
• Height: 8 Millimeter
• Height: 8 Millimeter
• Length: 25 Millimeter
• Width: 10 Millimeter
• Height: 8 Millimeter
• Length: 25 Millimeter
• Width: 10 Millimeter
• Height: 8 Millimeter
• Length: 25 Millimeter
• Width: 10 Millimeter
• Height: 8 Millimeter
• Length: 25 Millimeter
• Width: 10 Millimeter
• Height: 8 Millimeter
• Length: 25 Millimeter
• Width: 10 Millimeter
• Height: 8 Millimeter
• Length: 25 Millimeter
• Width: 10 Millimeter
• Height: 8 Millimeter
• Length: 25 Millimeter
• Width: 10 Millimeter
• Height: 8 Millimeter
• Length: 25 Millimeter
• Width: 10 Millimeter
• Height: 8 Millimeter
• Length: 25 Millimeter
• Width: 10 Millimeter
• Height: 8 Millimeter
• Length: 25 Millimeter
• Width: 10 Millimeter
• Height: 8 Millimeter
• Length: 25 Millimeter
• Width: 10 Millimeter
• Height: 8 Millimeter
• Length: 25 Millimeter
• Width: 10 Millimeter
• Height: 8 Millimeter
• Length: 25 Millimeter
• Width: 10 Millimeter
• Height: 8 Millimeter
• Length: 25 Millimeter
• Width: 10 Millimeter
• Height: 8 Millimeter
• Length: 25 Millimeter
• Width: 10 Millimeter
• Height: 8 Millimeter
• Length: 25 Millimeter
• Width: 10 Millimeter
• Height: 8 Millimeter
• Length: 25 Millimeter
• Width: 10 Millimeter
• Height: 8 Millimeter
• Length: 25 Millimeter
• Width: 10 Millimeter
• Height: 8 Millimeter
• Length: 25 Millimeter
• Width: 10 Millimeter
• Height: 8 Millimeter
• Length: 25 Millimeter
• Width: 10 Millimeter
• Height: 8 Millimeter
• Length: 25 Millimeter
• Width: 10 Millimeter
• Height: 8 Millimeter
• Length: 25 Millimeter
• Width: 10 Millimeter
• Height: 8 Millimeter
• Length: 25 Millimeter
• Width: 10 Millimeter
• Height: 8 Millimeter
• Length: 25 Millimeter
• Width: 10 Millimeter
• Height: 8 Millimeter
• Length: 25 Millimeter
• Width: 10 Millimeter
• Height: 8 Millimeter
• Length: 25 Millimeter
• Width: 10 Millimeter
• Height: 8 Millimeter
• Length: 25 Millimeter
• Width: 10 Millimeter
• Height: 8 Millimeter
• Length: 25 Millimeter
• Width: 10 Millimeter
• Height: 8 Millimeter
• Length: 25 Millimeter
• Width: 10 Millimeter
• Height: 8 Millimeter
• Length: 25 Millimeter
• Width: 10 Millimeter
• Height: 8 Millimeter
• Length: 25 Millimeter
• Width: 10 Millimeter
• Height: 8 Millimeter
• Length: 25 Millimeter
• Width: 10 Millimeter
• Height: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844856008908 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042201
• Premarket Notification: K080699

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

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

[00844856008908]

Moist Heat or Steam Sterilization

[00844856008908]

Moist Heat or Steam Sterilization

[00844856008908]

Moist Heat or Steam Sterilization

[00844856008908]

Moist Heat or Steam Sterilization

[00844856008908]

Moist Heat or Steam Sterilization

[00844856008908]

Moist Heat or Steam Sterilization

[00844856008908]

Moist Heat or Steam Sterilization

[00844856008908]

Moist Heat or Steam Sterilization

[00844856008908]

Moist Heat or Steam Sterilization

[00844856008908]

Moist Heat or Steam Sterilization

[00844856008908]

Moist Heat or Steam Sterilization

[00844856008908]

Moist Heat or Steam Sterilization

[00844856008908]

Moist Heat or Steam Sterilization

[00844856008908]

Moist Heat or Steam Sterilization

[00844856008908]

Moist Heat or Steam Sterilization

[00844856008908]

Moist Heat or Steam Sterilization

[00844856008908]

Moist Heat or Steam Sterilization

[00844856008908]

Moist Heat or Steam Sterilization

[00844856008908]

Moist Heat or Steam Sterilization

[00844856008908]

Moist Heat or Steam Sterilization

[00844856008908]

Moist Heat or Steam Sterilization

[00844856008908]

Moist Heat or Steam Sterilization

[00844856008908]

Moist Heat or Steam Sterilization

[00844856008908]

Moist Heat or Steam Sterilization

[00844856008908]

Moist Heat or Steam Sterilization

[00844856008908]

Moist Heat or Steam Sterilization

[00844856008908]

Moist Heat or Steam Sterilization

[00844856008908]

Moist Heat or Steam Sterilization

[00844856008908]

Moist Heat or Steam Sterilization

[00844856008908]

Moist Heat or Steam Sterilization

[00844856008908]

Moist Heat or Steam Sterilization

[00844856008908]

Moist Heat or Steam Sterilization

[00844856008908]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-08-31

On-Brand Devices [Novel Spinal Spacer System]

• 00844856066861: Novel SD, Self Distracting PEEK Cage, Wide, Novel, L, 20 mm
• 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