LIF AMP

GUDID 00190376422145

LIF AMP, ONE SCREW PLATE, 10 WITH CENTER SCREW, 10MM, AND CENTER SCREW - BACK TABLE

ALPHATEC SPINE, INC.

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 00190376422145
• NIH Device Record Key: 98789566-a6e0-4e39-a2d5-be0320d09835
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LIF AMP
• Version Model Number: 116-1-12-10-S
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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
• 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
• 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	00190376422145 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211805

FDA Product Code

• OVD: Intervertebral fusion device with integrated fixation, lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-11
• Device Publish Date: 2022-03-03

On-Brand Devices [LIF AMP]

• 00190376423371: LIF AMP, TWO SCREW PLATE, 16 WITH CENTER SCREW, 20MM, AND CENTER SCREW - BACK TABLE
• 00190376423357: LIF AMP, TWO SCREW PLATE, 14 WITH CENTER SCREW, 20MM, AND CENTER SCREW - BACK TABLE
• 00190376423333: LIF AMP, TWO SCREW PLATE, 12 WITH CENTER SCREW, 20MM, AND CENTER SCREW - BACK TABLE
• 00190376423319: LIF AMP, TWO SCREW PLATE, 12 WITH CENTER SCREW, 15MM, AND CENTER SCREW - BACK TABLE
• 00190376423296: LIF AMP, TWO SCREW PLATE, 10 WITH CENTER SCREW, 15MM, AND CENTER SCREW - BACK TABLE
• 00190376423272: LIF AMP, TWO SCREW PLATE, 10 WITH CENTER SCREW, 20MM, AND CENTER SCREW - BACK TABLE
• 00190376423258: LIF AMP, TWO SCREW PLATE, 08 WITH CENTER SCREW, 20MM, AND CENTER SCREW - BACK TABLE
• 00190376423234: LIF AMP, TWO SCREW PLATE, 06 WITH CENTER SCREW, 20MM, AND CENTER SCREW - BACK TABLE
• 00190376423210: LIF AMP, TWO SCREW PLATE, 04 WITH CENTER SCREW, 20MM, AND CENTER SCREW - BACK TABLE
• 00190376423203: LIF AMP, TWO SCREW PLATE, 16 WITH CENTER SCREW, 17.5MM, AND CENTER SCREW - BACK TABLE
• 00190376423180: LIF AMP, TWO SCREW PLATE, 14 WITH CENTER SCREW, 17.5MM, AND CENTER SCREW - BACK TABLE
• 00190376423166: LIF AMP, TWO SCREW PLATE, 12 WITH CENTER SCREW, 17.5MM, AND CENTER SCREW - BACK TABLE
• 00190376423142: LIF AMP, TWO SCREW PLATE, 10 WITH CENTER SCREW, 17.5MM, AND CENTER SCREW - BACK TABLE
• 00190376423128: LIF AMP, TWO SCREW PLATE, 08 WITH CENTER SCREW, 17.5MM, AND CENTER SCREW - BACK TABLE
• 00190376423104: LIF AMP, TWO SCREW PLATE, 06 WITH CENTER SCREW, 17.5MM, AND CENTER SCREW - BACK TABLE
• 00190376423081: LIF AMP, TWO SCREW PLATE, 04 WITH CENTER SCREW, 17.5MM, AND CENTER SCREW - BACK TABLE
• 00190376423074: LIF AMP, TWO SCREW PLATE, 16 WITH CENTER SCREW, 15MM, AND CENTER SCREW - BACK TABLE
• 00190376423050: LIF AMP, TWO SCREW PLATE, 14 WITH CENTER SCREW, 15MM, AND CENTER SCREW - BACK TABLE
• 00190376423036: LIF AMP, TWO SCREW PLATE, 08 WITH CENTER SCREW, 15MM, AND CENTER SCREW - BACK TABLE
• 00190376423012: LIF AMP, TWO SCREW PLATE, 06 WITH CENTER SCREW, 15MM, AND CENTER SCREW - BACK TABLE
• 00190376422992: LIF AMP, TWO SCREW PLATE, 04 WITH CENTER SCREW, 15MM, AND CENTER SCREW - BACK TABLE
• 00190376422985: LIF AMP, TWO SCREW PLATE, 16 WITH CENTER SCREW, 12.5MM, AND CENTER SCREW - BACK TABLE
• 00190376422961: LIF AMP, TWO SCREW PLATE, 14 WITH CENTER SCREW, 12.5MM, AND CENTER SCREW - BACK TABLE
• 00190376422947: LIF AMP, TWO SCREW PLATE, 12 WITH CENTER SCREW, 12.5MM, AND CENTER SCREW - BACK TABLE
• 00190376422923: LIF AMP, TWO SCREW PLATE, 10 WITH CENTER SCREW, 12.5MM, AND CENTER SCREW - BACK TABLE
• 00190376422909: LIF AMP, TWO SCREW PLATE, 08 WITH CENTER SCREW, 12.5MM, AND CENTER SCREW - BACK TABLE
• 00190376422886: LIF AMP, TWO SCREW PLATE, 06 WITH CENTER SCREW, 12.5MM, AND CENTER SCREW - BACK TABLE
• 00190376422862: LIF AMP, TWO SCREW PLATE, 04 WITH CENTER SCREW, 12.5MM, AND CENTER SCREW - BACK TABLE
• 00190376422855: LIF AMP, TWO SCREW PLATE, 16 WITH CENTER SCREW, 10MM, AND CENTER SCREW - BACK TABLE
• 00190376422831: LIF AMP, TWO SCREW PLATE, 14 WITH CENTER SCREW, 10MM, AND CENTER SCREW - BACK TABLE
• 00190376422817: LIF AMP, TWO SCREW PLATE, 12 WITH CENTER SCREW, 10MM, AND CENTER SCREW - BACK TABLE
• 00190376422794: LIF AMP, TWO SCREW PLATE, 10 WITH CENTER SCREW, 10MM, AND CENTER SCREW - BACK TABLE
• 00190376422770: LIF AMP, TWO SCREW PLATE, 08 WITH CENTER SCREW, 10MM, AND CENTER SCREW - BACK TABLE
• 00190376422756: LIF AMP, TWO SCREW PLATE, 06 WITH CENTER SCREW, 10MM, AND CENTER SCREW - BACK TABLE
• 00190376422732: LIF AMP, TWO SCREW PLATE, 04 WITH CENTER SCREW, 10MM, AND CENTER SCREW - BACK TABLE
• 00190376422725: LIF AMP, ONE SCREW PLATE, 16 WITH CENTER SCREW, 20MM, AND CENTER SCREW - BACK TABLE
• 00190376422701: LIF AMP, ONE SCREW PLATE, 14 WITH CENTER SCREW, 20MM, AND CENTER SCREW - BACK TABLE
• 00190376422688: LIF AMP, ONE SCREW PLATE, 12 WITH CENTER SCREW, 20MM, AND CENTER SCREW - BACK TABLE
• 00190376422664: LIF AMP, ONE SCREW PLATE, 10 WITH CENTER SCREW, 20MM, AND CENTER SCREW - BACK TABLE
• 00190376422640: LIF AMP, ONE SCREW PLATE, 08 WITH CENTER SCREW, 20MM, AND CENTER SCREW - BACK TABLE
• 00190376422626: LIF AMP, ONE SCREW PLATE, 06 WITH CENTER SCREW, 20MM, AND CENTER SCREW - BACK TABLE
• 00190376422602: LIF AMP, ONE SCREW PLATE, 04 WITH CENTER SCREW, 20MM, AND CENTER SCREW - BACK TABLE
• 00190376422596: LIF AMP, ONE SCREW PLATE, 16 WITH CENTER SCREW, 17.5MM, AND CENTER SCREW - BACK TABLE
• 00190376422572: LIF AMP, ONE SCREW PLATE, 14 WITH CENTER SCREW, 17.5MM, AND CENTER SCREW - BACK TABLE
• 00190376422558: LIF AMP, ONE SCREW PLATE, 12 WITH CENTER SCREW, 17.5MM, AND CENTER SCREW - BACK TABLE
• 00190376422534: LIF AMP, ONE SCREW PLATE, 10 WITH CENTER SCREW, 17.5MM, AND CENTER SCREW - BACK TABLE
• 00190376422510: LIF AMP, ONE SCREW PLATE, 08 WITH CENTER SCREW, 17.5MM, AND CENTER SCREW - BACK TABLE
• 00190376422497: LIF AMP, ONE SCREW PLATE, 06 WITH CENTER SCREW, 17.5MM, AND CENTER SCREW - BACK TABLE
• 00190376422473: LIF AMP, ONE SCREW PLATE, 04 WITH CENTER SCREW, 17.5MM, AND CENTER SCREW - BACK TABLE
• 00190376422466: LIF AMP, ONE SCREW PLATE, 16 WITH CENTER SCREW, 15MM, AND CENTER SCREW - BACK TABLE