Isobar

GUDID 03661380008825

Monoaxial hemispherical screw Ø 5.5 Lg 50 mm

SCIENT'X

Bone-screw internal spinal fixation system, sterile

• Primary Device ID: 03661380008825
• NIH Device Record Key: 92001f4b-613e-4133-8b9b-1affe6782c82
• Commercial Distribution Discontinuation: 2023-12-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Isobar
• Version Model Number: 12VDHD55-50
• Company DUNS: 502816283
• Company Name: SCIENT'X
• 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)494-6840
• Email: mfunk@alphatecspine.com
• Phone: +1(760)494-6840
• Email: mfunk@alphatecspine.com
• Phone: +1(760)494-6840
• Email: mfunk@alphatecspine.com
• Phone: +1(760)494-6840
• Email: mfunk@alphatecspine.com
• Phone: +1(760)494-6840
• Email: mfunk@alphatecspine.com
• Phone: +1(760)494-6840
• Email: mfunk@alphatecspine.com
• Phone: +1(760)494-6840
• Email: mfunk@alphatecspine.com
• Phone: +1(760)494-6840
• Email: mfunk@alphatecspine.com
• Phone: +1(760)494-6840
• Email: mfunk@alphatecspine.com
• Phone: +1(760)494-6840
• Email: mfunk@alphatecspine.com
• Phone: +1(760)494-6840
• Email: mfunk@alphatecspine.com
• Phone: +1(760)494-6840
• Email: mfunk@alphatecspine.com
• Phone: +1(760)494-6840
• Email: mfunk@alphatecspine.com
• Phone: +1(760)494-6840
• Email: mfunk@alphatecspine.com
• Phone: +1(760)494-6840
• Email: mfunk@alphatecspine.com
• Phone: +1(760)494-6840
• Email: mfunk@alphatecspine.com
• Phone: +1(760)494-6840
• Email: mfunk@alphatecspine.com
• Phone: +1(760)494-6840
• Email: mfunk@alphatecspine.com
• Phone: +1(760)494-6840
• Email: mfunk@alphatecspine.com
• Phone: +1(760)494-6840
• Email: mfunk@alphatecspine.com
• Phone: +1(760)494-6840
• Email: mfunk@alphatecspine.com
• Phone: +1(760)494-6840
• Email: mfunk@alphatecspine.com
• Phone: +1(760)494-6840
• Email: mfunk@alphatecspine.com
• Phone: +1(760)494-6840
• Email: mfunk@alphatecspine.com
• Phone: +1(760)494-6840
• Email: mfunk@alphatecspine.com
• Phone: +1(760)494-6840
• Email: mfunk@alphatecspine.com
• Phone: +1(760)494-6840
• Email: mfunk@alphatecspine.com
• Phone: +1(760)494-6840
• Email: mfunk@alphatecspine.com
• Phone: +1(760)494-6840
• Email: mfunk@alphatecspine.com

Device Dimensions

• Outer Diameter: 5.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 50 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	03661380008825 [Primary]

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[03661380008825]

Moist Heat or Steam Sterilization

[03661380008825]

Moist Heat or Steam Sterilization

[03661380008825]

Moist Heat or Steam Sterilization

[03661380008825]

Moist Heat or Steam Sterilization

[03661380008825]

Moist Heat or Steam Sterilization

[03661380008825]

Moist Heat or Steam Sterilization

[03661380008825]

Moist Heat or Steam Sterilization

[03661380008825]

Moist Heat or Steam Sterilization

[03661380008825]

Moist Heat or Steam Sterilization

[03661380008825]

Moist Heat or Steam Sterilization

[03661380008825]

Moist Heat or Steam Sterilization

[03661380008825]

Moist Heat or Steam Sterilization

[03661380008825]

Moist Heat or Steam Sterilization

[03661380008825]

Moist Heat or Steam Sterilization

[03661380008825]

Moist Heat or Steam Sterilization

[03661380008825]

Moist Heat or Steam Sterilization

[03661380008825]

Moist Heat or Steam Sterilization

[03661380008825]

Moist Heat or Steam Sterilization

[03661380008825]

Moist Heat or Steam Sterilization

[03661380008825]

Moist Heat or Steam Sterilization

[03661380008825]

Moist Heat or Steam Sterilization

[03661380008825]

Moist Heat or Steam Sterilization

[03661380008825]

Moist Heat or Steam Sterilization

[03661380008825]

Moist Heat or Steam Sterilization

[03661380008825]

Moist Heat or Steam Sterilization

[03661380008825]

Moist Heat or Steam Sterilization

[03661380008825]

Moist Heat or Steam Sterilization

[03661380008825]

Moist Heat or Steam Sterilization

[03661380008825]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2024-06-25
• Device Publish Date: 2015-09-10