Zodiac Spinal Fixation System

GUDID 00844856003835

Ti 4.0mm Monoaxial Pedicle Screw, 25mm

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: 00844856003835
• NIH Device Record Key: 21c47174-b759-45b3-875f-637316b7e8e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zodiac Spinal Fixation System
• Version Model Number: 62240-25
• 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

Device Dimensions

• Outer Diameter: 4 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 4 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844856003835 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071890
• Premarket Notification: K100685

FDA Product Code

• MNH: Orthosis, spondylolisthesis spinal fixation

Sterilization

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

[00844856003835]

Moist Heat or Steam Sterilization

[00844856003835]

Moist Heat or Steam Sterilization

[00844856003835]

Moist Heat or Steam Sterilization

[00844856003835]

Moist Heat or Steam Sterilization

[00844856003835]

Moist Heat or Steam Sterilization

[00844856003835]

Moist Heat or Steam Sterilization

[00844856003835]

Moist Heat or Steam Sterilization

[00844856003835]

Moist Heat or Steam Sterilization

[00844856003835]

Moist Heat or Steam Sterilization

[00844856003835]

Moist Heat or Steam Sterilization

[00844856003835]

Moist Heat or Steam Sterilization

[00844856003835]

Moist Heat or Steam Sterilization

[00844856003835]

Moist Heat or Steam Sterilization

[00844856003835]

Moist Heat or Steam Sterilization

[00844856003835]

Moist Heat or Steam Sterilization

[00844856003835]

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: 2015-08-31

On-Brand Devices [Zodiac Spinal Fixation System]

• 00844856069404: 6.35mm Adjustable Bridge, Large
• 00844856069398: 6.35mm Adjustable Bridge, Medium
• 00844856069381: 6.35mm Adjustable Bridge, Small
• 00844856069374: 6.35mm Adjustable Bridge, X Small
• 00844856069367: 6.35mm Adjustable Bridge, XX Small
• 00844856069350: SS Iliac Bone Screw, 8.5mm X 75mm X 30
• 00844856069343: SS Iliac Bone Screw, 8.5mm X 75mm X 15
• 00844856069336: SS Iliac Bone Screw, 8.5mm X 65mm X 30
• 00844856069329: SS Iliac Bone Screw, 8.5mm X 65mm X 15
• 00844856069312: SS Iliac Bone Screw, 8.5mm X 55mm X 30
• 00844856069305: SS Iliac Bone Screw, 8.5mm X 55mm X 15
• 00844856069299: SS Iliac Bone Screw, 8.5mm X 45mm X 30
• 00844856069282: SS Iliac Bone Screw, 8.5mm X 45mm X 15
• 00844856069275: SS Iliac Bone Screw, 8.5mm X 35mm X 30
• 00844856069268: SS Iliac Bone Screw, 8.5mm X 35mm X 15
• 00844856069251: SS Iliac Bone Screw, 8.5mm X 30mm X 30
• 00844856069244: SS Iliac Bone Screw, 8.5mm X 30mm X 15
• 00844856069237: SS Iliac Bone Screw, 8.5mm X 25mm X 30
• 00844856069220: SS Iliac Bone Screw, 8.5mm X 25mm X 15
• 00844856069213: SS Iliac Bone Screw, 7.5mm X 75mm X 30
• 00844856069206: SS Iliac Bone Screw, 7.5mm X 75mm X 15
• 00844856069190: SS Iliac Bone Screw, 7.5mm X 65mm X 30
• 00844856069183: SS Iliac Bone Screw, 7.5mm X 65mm X 15
• 00844856069176: SS Iliac Bone Screw, 7.5mm X 55mm X 30
• 00844856069169: SS Iliac Bone Screw, 7.5mm X 55mm X 15
• 00844856069152: SS Iliac Bone Screw, 7.5mm X 45mm X 30
• 00844856069145: SS Iliac Bone Screw, 7.5mm X 45mm X 15
• 00844856069138: SS Iliac Bone Screw, 7.5mm X 35mm X 30
• 00844856069121: SS Iliac Bone Screw, 7.5mm X 35mm X 15
• 00844856069114: SS Iliac Bone Screw, 7.5mm X 30mm X 30
• 00844856069107: SS Iliac Bone Screw, 7.5mm X 30mm X 15
• 00844856069091: SS Iliac Bone Screw, 7.5mm X 25mm X 30
• 00844856069084: SS Iliac Bone Screw, 7.5mm X 25mm X 15
• 00844856069077: SS Pedicle Hook, Medium Lipped
• 00844856069060: SS Laminar Hook, Medium Extended Body
• 00844856069053: SS Laminar Hook, Small Extended Body
• 00844856069046: SS 8.5mm Monoaxial Pedicle Screw, 75mm
• 00844856069039: SS 8.5mm Monoaxial Pedicle Screw, 65mm
• 00844856069022: SS 8.5MM POLYAXIAL Screw ASSY, 95mm
• 00844856069015: SS 8.5MM POLYAXIAL Screw ASSY, 90mm
• 00844856069008: SS 8.5MM POLYAXIAL Screw ASSY, 85mm
• 00844856068995: SS 8.5mm Polyaxial Screw Assy, 100mm
• 00844856068988: SS ROD 5.5MM DIA X 45CM - 90DEG LASERMARK
• 00844856068971: SS ROD 5.5MM DIA X 30CM - 90DEG LASERMARK
• 00844856068964: SS ROD 5.5MM DIA X 25CM - 90DEG LASERMARK
• 00844856068957: SS-Rod 5.5mm x 45cm
• 00844856068940: SS-Rod 5.5mm x 30cm
• 00844856068933: SS-Rod 5.5mm x 25cm
• 00844856068926: SS-Rod 5.5mm x 20cm
• 00844856068919: SS-Rod 5.5mm x 17cm