SOLANAS AVALON Posterior OccipitoCervicoThoracic (OCT) Fixation System

GUDID 00844856068780

4.5mm Occipital Bone Screw, 10mm

ALPHATEC SPINE, INC.

Bone-screw internal spinal fixation system 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: 00844856068780
• NIH Device Record Key: 789fdedf-d3b3-470b-aa35-a339fffeb5ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOLANAS AVALON Posterior OccipitoCervicoThoracic (OCT) Fixation System
• Version Model Number: 75045-010
• 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

• Length: 10 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 10 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844856068780 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111076

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[00844856068780]

Moist Heat or Steam Sterilization

[00844856068780]

Moist Heat or Steam Sterilization

[00844856068780]

Moist Heat or Steam Sterilization

[00844856068780]

Moist Heat or Steam Sterilization

[00844856068780]

Moist Heat or Steam Sterilization

[00844856068780]

Moist Heat or Steam Sterilization

[00844856068780]

Moist Heat or Steam Sterilization

[00844856068780]

Moist Heat or Steam Sterilization

[00844856068780]

Moist Heat or Steam Sterilization

[00844856068780]

Moist Heat or Steam Sterilization

[00844856068780]

Moist Heat or Steam Sterilization

[00844856068780]

Moist Heat or Steam Sterilization

[00844856068780]

Moist Heat or Steam Sterilization

[00844856068780]

Moist Heat or Steam Sterilization

[00844856068780]

Moist Heat or Steam Sterilization

[00844856068780]

Moist Heat or Steam Sterilization

[00844856068780]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-24

On-Brand Devices [SOLANAS AVALON Posterior OccipitoCervicoThoracic (OCT) Fixation System]

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• 00844856074163: 5.0mm Occipital Bone Screw, 13mm
• 00844856074156: 5.0mm Occipital Bone Screw, 11mm
• 00844856074149: 5.0mm Occipital Bone Screw, 9mm
• 00844856074132: 5.0mm Occipital Bone Screw, 7mm
• 00844856074125: 4.5mm Occipital Bone Screw, 15mm
• 00844856074118: 4.5mm Occipital Bone Screw, 13mm
• 00844856074101: 4.5mm Occipital Bone Screw, 11mm
• 00844856074095: 4.5mm Occipital Bone Screw, 9mm
• 00844856074088: 4.5mm Occipital Bone Screw, 7mm
• 00844856068872: 5.0mm Occipital Bone Screw, 16mm
• 00844856068865: 5.0mm Occipital Bone Screw, 14mm
• 00844856068858: 5.0mm Occipital Bone Screw, 12mm
• 00844856068841: 5.0mm Occipital Bone Screw, 10mm
• 00844856068834: 5.0mm Occipital Bone Screw, 8mm
• 00844856068827: 5.0mm Occipital Bone Screw, 6mm
• 00844856068810: 4.5mm Occipital Bone Screw, 16mm
• 00844856068803: 4.5mm Occipital Bone Screw, 14mm
• 00844856068797: 4.5mm Occipital Bone Screw, 12mm
• 00844856068780: 4.5mm Occipital Bone Screw, 10mm
• 00844856068773: 4.5mm Occipital Bone Screw, 8mm
• 00844856068766: 4.5mm Occipital Bone Screw, 6mm
• 00844856068759: Occipital Pre-Contoured Transition Rod
• 00844856068735: Occipital Plate Assembly, 66mm
• 00844856068728: Occipital Plate Assembly, 56mm
• 00844856000001: Occipital Plate Set Screw
• 00844856068742: OCCIPITAL PLATE SET SCREW