Invictus OsseoScrew

GUDID 00190376243863

Invictus Osseoscrew, Polyaxial, 7.5 X 40mm

ALPHATEC SPINE, INC.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00190376243863
• NIH Device Record Key: 46e2e1f6-8302-4db6-83ac-c1c4437e69b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Invictus OsseoScrew
• Version Model Number: 15905-075-040
• 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

Device Dimensions

• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter
• Outer Diameter: 7.5 Millimeter
• Length: 40 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190376243863 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202327

FDA Product Code

• NKB: Thoracolumbosacral pedicle screw system

Sterilization

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

[00190376243863]

Moist Heat or Steam Sterilization

[00190376243863]

Moist Heat or Steam Sterilization

[00190376243863]

Moist Heat or Steam Sterilization

[00190376243863]

Moist Heat or Steam Sterilization

[00190376243863]

Moist Heat or Steam Sterilization

[00190376243863]

Moist Heat or Steam Sterilization

[00190376243863]

Moist Heat or Steam Sterilization

[00190376243863]

Moist Heat or Steam Sterilization

[00190376243863]

Moist Heat or Steam Sterilization

[00190376243863]

Moist Heat or Steam Sterilization

[00190376243863]

Moist Heat or Steam Sterilization

[00190376243863]

Moist Heat or Steam Sterilization

[00190376243863]

Moist Heat or Steam Sterilization

[00190376243863]

Moist Heat or Steam Sterilization

[00190376243863]

Moist Heat or Steam Sterilization

[00190376243863]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-15
• Device Publish Date: 2021-02-06

On-Brand Devices [Invictus OsseoScrew]

• 00190376307350: Osseoscrew Ratcheting Egg Handle, Cannulated
• 00190376307343: Osseoscrew, Collapse Handle
• 00190376307336: Invictus Osseoscrew, Expansion Shaft, 55 mm
• 00190376307329: Invictus Osseoscrew, Expansion Shaft, 50 mm
• 00190376307312: Invictus Osseoscrew, Expansion Shaft, 45 mm
• 00190376307305: Invictus Osseoscrew, Expansion Shaft, 40 mm
• 00190376301709: Osseoscrew Trial Probe, Right, Cannulated
• 00190376301693: Osseoscrew Trial Probe, Left, Cannulated
• 00190376301686: Osseoscrew Expansion T Handle
• 00190376301679: Osseoscrew Trial Marker, Right
• 00190376301662: Osseoscrew Trial Marker, Left
• 00190376244549: Invictus Osseoscrew, Extended Tab, 7.5 X 55mm
• 00190376244532: Invictus Osseoscrew, Extended Tab, 7.5 X 50mm
• 00190376244525: Invictus Osseoscrew, Extended Tab, 7.5 X 45mm
• 00190376244518: Invictus Osseoscrew, Extended Tab, 7.5 X 40mm
• 00190376244402: Invictus Osseoscrew, Extended Tab, 6.5 X 55mm
• 00190376244396: Invictus Osseoscrew, Extended Tab, 6.5 X 50mm
• 00190376244389: Invictus Osseoscrew, Extended Tab, 6.5 X 45mm
• 00190376244372: Invictus Osseoscrew, Extended Tab, 6.5 X 40mm
• 00190376244242: Invictus Osseoscrew, Reduction, 7.5 X 55mm
• 00190376244235: Invictus Osseoscrew, Reduction, 7.5 X 50mm
• 00190376244228: Invictus Osseoscrew, Reduction, 7.5 X 45mm
• 00190376244211: Invictus Osseoscrew, Reduction, 7.5 X 40mm
• 00190376244105: Invictus Osseoscrew, Reduction, 6.5 X 55mm
• 00190376244099: Invictus Osseoscrew, Reduction, 6.5 X 50mm
• 00190376244082: Invictus Osseoscrew, Reduction, 6.5 X 45mm
• 00190376244075: Invictus Osseoscrew, Reduction, 6.5 X 40mm
• 00190376243962: Invictus Osseoscrew, Polyaxial, 7.5 X 55mm
• 00190376243887: Invictus Osseoscrew, Polyaxial, 7.5 X 50mm
• 00190376243870: Invictus Osseoscrew, Polyaxial, 7.5 X 45mm
• 00190376243863: Invictus Osseoscrew, Polyaxial, 7.5 X 40mm
• 00190376243849: Invictus Osseoscrew, Polyaxial, 6.5 X 55mm
• 00190376243832: Invictus Osseoscrew, Polyaxial, 6.5 X 50mm
• 00190376243825: Invictus Osseoscrew, Polyaxial, 6.5 X 45mm
• 00190376243818: Invictus Osseoscrew, Polyaxial, 6.5 X 40mm
• 00190376381657: Invictus Osseoscrew, Expansion Shaft 55mm
• 00190376381640: Invictus Osseoscrew, Expansion Shaft 50mm
• 00190376381633: Invictus Osseoscrew, Expansion Shaft 45mm
• 00190376381626: Invictus Osseoscrew, Expansion Shaft 40mm
• 00190376381725: Invictus Osseoscrew, Expansion Shaft 55mm
• 00190376381701: Invictus Osseoscrew, Expansion Shaft 50mm
• 00190376381688: Invictus Osseoscrew, Expansion Shaft 45mm
• 00190376381664: Invictus Osseoscrew, Expansion Shaft 40mm
• 00190376349299: Invictus Osseoscrew Tap, 7.5mm, Cannulated
• 00190376349282: Invictus Osseoscrew Tap, 6.5mm, Cannulated
• 00190376349275: Invictus Osseoscrew Tap, 5.5mm, Cannulated
• 00190376349268: Osseoscrew, Collapse Handle
• 00190376349251: Osseoscrew Trial Probe, Right, Cannulated
• 00190376349244: Osseoscrew Trial Probe, Left, Cannulated
• 00190376349237: Osseoscrew Expansion T Handle