Osseofix +

GUDID 00844856032231

Osseofix + Radiopaque Cement

ALPHATEC SPINE, INC.

Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable

• Primary Device ID: 00844856032231
• NIH Device Record Key: 72c3420a-6cff-4436-8501-924fc18c0c78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Osseofix +
• Version Model Number: 21390
• Company DUNS: 602465783
• Company Name: ALPHATEC SPINE, INC.
• Device Count: 2
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844856032231 [Primary]
GS1	10844856032238 [Unit of Use]

FDA Product Code

• NDN: CEMENT, BONE, VERTEBROPLASTY

Sterilization

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

[00844856032231]

Radiation Sterilization;Ethylene Oxide

[00844856032231]

Radiation Sterilization

[00844856032231]

Radiation Sterilization

[00844856032231]

Radiation Sterilization

[00844856032231]

Radiation Sterilization

[00844856032231]

Radiation Sterilization

[00844856032231]

Radiation Sterilization

[00844856032231]

Radiation Sterilization

[00844856032231]

Radiation Sterilization

[00844856032231]

Radiation Sterilization

[00844856032231]

Radiation Sterilization

[00844856032231]

Radiation Sterilization

[00844856032231]

Radiation Sterilization

[00844856032231]

Radiation Sterilization

[00844856032231]

Radiation Sterilization

[00844856032231]

Radiation Sterilization

[00844856032231]

Radiation Sterilization

[00844856032231]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-10-28

On-Brand Devices [Osseofix +]

• 00376017704882: Osseofix + Radiopaque Cement
• 00844856032231: Osseofix + Radiopaque Cement