AMP

GUDID 00190376151571

LLIF AMP, 5.5mm x 30mm BONE SCREW

ALPHATEC SPINE, INC.

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 00190376151571
• NIH Device Record Key: dfbbb57a-d409-44cf-a596-796ec8b34baf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMP
• Version Model Number: 116-04-5530
• 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)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 Dimensions

• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 30 Millimeter
• Outer Diameter: 5.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190376151571 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191311

FDA Product Code

• OVD: Intervertebral fusion device with integrated fixation, lumbar

Sterilization

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

[00190376151571]

Moist Heat or Steam Sterilization

[00190376151571]

Moist Heat or Steam Sterilization

[00190376151571]

Moist Heat or Steam Sterilization

[00190376151571]

Moist Heat or Steam Sterilization

[00190376151571]

Moist Heat or Steam Sterilization

[00190376151571]

Moist Heat or Steam Sterilization

[00190376151571]

Moist Heat or Steam Sterilization

[00190376151571]

Moist Heat or Steam Sterilization

[00190376151571]

Moist Heat or Steam Sterilization

[00190376151571]

Moist Heat or Steam Sterilization

[00190376151571]

Moist Heat or Steam Sterilization

[00190376151571]

Moist Heat or Steam Sterilization

[00190376151571]

Moist Heat or Steam Sterilization

[00190376151571]

Moist Heat or Steam Sterilization

[00190376151571]

Moist Heat or Steam Sterilization

[00190376151571]

Moist Heat or Steam Sterilization

[00190376151571]

Moist Heat or Steam Sterilization

[00190376151571]

Moist Heat or Steam Sterilization

[00190376151571]

Moist Heat or Steam Sterilization

[00190376151571]

Moist Heat or Steam Sterilization

[00190376151571]

Moist Heat or Steam Sterilization

[00190376151571]

Moist Heat or Steam Sterilization

[00190376151571]

Moist Heat or Steam Sterilization

[00190376151571]

Moist Heat or Steam Sterilization

[00190376151571]

Moist Heat or Steam Sterilization

[00190376151571]

Moist Heat or Steam Sterilization

[00190376151571]

Moist Heat or Steam Sterilization

[00190376151571]

Moist Heat or Steam Sterilization

[00190376151571]

Moist Heat or Steam Sterilization

[00190376151571]

Moist Heat or Steam Sterilization

[00190376151571]

Moist Heat or Steam Sterilization

[00190376151571]

Moist Heat or Steam Sterilization

[00190376151571]

Moist Heat or Steam Sterilization

[00190376151571]

Moist Heat or Steam Sterilization

[00190376151571]

Moist Heat or Steam Sterilization

[00190376151571]

Moist Heat or Steam Sterilization

[00190376151571]

Moist Heat or Steam Sterilization

[00190376151571]

Moist Heat or Steam Sterilization

[00190376151571]

Moist Heat or Steam Sterilization

[00190376151571]

Moist Heat or Steam Sterilization

[00190376151571]

Moist Heat or Steam Sterilization

[00190376151571]

Moist Heat or Steam Sterilization

[00190376151571]

Moist Heat or Steam Sterilization

[00190376151571]

Moist Heat or Steam Sterilization

[00190376151571]

Moist Heat or Steam Sterilization

[00190376151571]

Moist Heat or Steam Sterilization

[00190376151571]

Moist Heat or Steam Sterilization

[00190376151571]

Moist Heat or Steam Sterilization

[00190376151571]

Moist Heat or Steam Sterilization

[00190376151571]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-20
• Device Publish Date: 2020-01-10

On-Brand Devices [AMP]

• 00190376206288: LIF AMP, TWO SCREW PLATE, 05
• 00190376206271: LIF AMP, TWO SCREW PLATE, 04
• 00190376206264: LIF AMP, ONE SCREW PLATE, 16
• 00190376206257: LIF AMP, ONE SCREW PLATE, 15
• 00190376206240: LIF AMP, ONE SCREW PLATE, 14
• 00190376206233: LIF AMP, ONE SCREW PLATE, 13
• 00190376206226: LIF AMP, ONE SCREW PLATE, 12
• 00190376206219: LIF AMP, ONE SCREW PLATE, 11
• 00190376206202: LIF AMP, ONE SCREW PLATE, 10
• 00190376206196: LIF AMP, ONE SCREW PLATE, 09
• 00190376206189: LIF AMP, ONE SCREW PLATE, 08
• 00190376206172: LIF AMP, ONE SCREW PLATE, 07
• 00190376206165: LIF AMP, ONE SCREW PLATE, 06
• 00190376206158: LIF AMP, ONE SCREW PLATE, 05
• 00190376206141: LIF AMP, ONE SCREW PLATE, 04
• 00190376206134: LIF AMP, Ø6.5mm x 65mm BONE SCREW
• 00190376206127: LIF AMP, Ø6.5mm x 60mm BONE SCREW
• 00190376206110: LIF AMP, Ø6.5mm x 55mm BONE SCREW
• 00190376206103: LIF AMP, Ø6.5mm x 50mm BONE SCREW
• 00190376206097: LIF AMP, Ø6.5mm x 45mm BONE SCREW
• 00190376206080: LIF AMP, Ø6.5mm x 40mm BONE SCREW
• 00190376206073: LIF AMP, Ø6.5mm x 35mm BONE SCREW
• 00190376206066: LIF AMP, Ø6.5mm x 30mm BONE SCREW
• 00190376206059: LIF AMP, Ø6.5mm x 25mm BONE SCREW
• 00190376206042: LIF AMP, Ø6.0mm x 65mm BONE SCREW
• 00190376206035: LIF AMP, Ø6mm x 60mm BONE SCREW
• 00190376206028: LIF AMP, Ø6mm x 55mm BONE SCREW
• 00190376206011: LIF AMP, Ø6mm x 50mm BONE SCREW
• 00190376206004: LIF AMP, Ø6mm x 45mm BONE SCREW
• 00190376205991: LIF AMP, Ø6mm x 40mm BONE SCREW
• 00190376205984: LIF AMP, Ø6mm x 35mm BONE SCREW
• 00190376205977: LIF AMP, Ø6mm x 30mm BONE SCREW
• 00190376205960: LIF AMP, Ø6mm x 25mm BONE SCREW
• 00190376205953: LIF AMP, Ø5.5mm x 65mm BONE SCREW
• 00190376205946: LIF AMP, Ø5.5mm x 60mm BONE SCREW
• 00190376205939: LIF AMP, Ø5.5mm x 55mm BONE SCREW
• 00190376205922: LIF AMP, Ø5.5mm x 50mm BONE SCREW
• 00190376205915: LIF AMP, Ø5.5mm x 45mm BONE SCREW
• 00190376205908: LIF AMP, Ø5.5mm x 40mm BONE SCREW
• 00190376205892: LIF AMP, Ø5.5mm x 35mm BONE SCREW
• 00190376205885: LIF AMP, Ø5.5mm x 30mm BONE SCREW
• 00190376205878: LIF AMP, Ø5.5mm x 25mm BONE SCREW
• 00190376205861: LIF AMP, CENTER SCREW, 20mm
• 00190376205854: LIF AMP, CENTER SCREW, 17.5mm
• 00190376205847: LIF AMP, CENTER SCREW, 15mm
• 00190376205830: LIF AMP, CENTER SCREW, 12.5mm
• 00190376205823: LIF AMP, CENTER SCREW, 10mm
• 00190376205816: LIF AMP, TWO SCREW PLATE, 16
• 00190376205809: LIF AMP, TWO SCREW PLATE, 15
• 00190376205793: LIF AMP, TWO SCREW PLATE, 14