ZIP

GUDID B52100104045

ZIP All-In-One Compressor 45mm

AURORA SPINE, INC.

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile

• Primary Device ID: B52100104045
• NIH Device Record Key: e510f2ff-c8bd-4ec1-a9d2-44ad9c44e5eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZIP
• Version Model Number: 001-040-45
• Company DUNS: 079119091
• Company Name: AURORA SPINE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B52100104045 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[B52100104045]

Moist Heat or Steam Sterilization

[B52100104045]

Moist Heat or Steam Sterilization

[B52100104045]

Moist Heat or Steam Sterilization

[B52100104045]

Moist Heat or Steam Sterilization

[B52100104045]

Moist Heat or Steam Sterilization

[B52100104045]

Moist Heat or Steam Sterilization

[B52100104045]

Moist Heat or Steam Sterilization

[B52100104045]

Moist Heat or Steam Sterilization

[B52100104045]

Moist Heat or Steam Sterilization

[B52100104045]

Moist Heat or Steam Sterilization

[B52100104045]

Moist Heat or Steam Sterilization

[B52100104045]

Moist Heat or Steam Sterilization

[B52100104045]

Moist Heat or Steam Sterilization

[B52100104045]

Moist Heat or Steam Sterilization

[B52100104045]

Moist Heat or Steam Sterilization

[B52100104045]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-11
• Device Publish Date: 2022-02-03

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• B5211040120370: ZIP 51 MIS Interspinous Fusion System, 12mm x 37mm
• B5211040120350: ZIP 51 MIS Interspinous Fusion System, 12mm x 35mm
• B5211040100430: ZIP 51 MIS Interspinous Fusion System, 10mm x 43mm
• B5211040100410: ZIP 51 MIS Interspinous Fusion System, 10mm x 41mm
• B5211040100390: ZIP 51 MIS Interspinous Fusion System, 10mm x 39mm
• B5211040100370: ZIP 51 MIS Interspinous Fusion System, 10mm x 37mm
• B5211040100350: ZIP 51 MIS Interspinous Fusion System, 10mm x 35mm
• B5211040080430: ZIP 51 MIS Interspinous Fusion System, 8mm x 43mm
• B5211040080410: ZIP 51 MIS Interspinous Fusion System, 8mm x 41mm
• B5211040080390: ZIP 51 MIS Interspinous Fusion System, 8mm x 39mm
• B5211040080370: ZIP 51 MIS Interspinous Fusion System, 8mm x 37mm
• B5211040080350: ZIP 51 MIS Interspinous Fusion System, 8mm x 35mm
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• B5211030160450: ZIP LP MIS Interspinous Fusion System, 16mm X 45mm
• B5211030160400: ZIP LP MIS Interspinous Fusion System, 16mm X 40mm
• B5211030140450: ZIP LP MIS Interspinous Fusion System, 14mm X 45mm
• B5211030140400: ZIP LP MIS Interspinous Fusion System, 14mm X 40mm
• B5211030140350: ZIP LP MIS Interspinous Fusion System, 14mm X 35mm
• B5211030120450: ZIP LP MIS Interspinous Fusion System, 12mm X 45mm
• B5211030120400: ZIP LP MIS Interspinous Fusion System, 12mm X 40mm
• B5211030120350: ZIP LP MIS Interspinous Fusion System, 12mm X 35mm
• B5211030100450: ZIP LP MIS Interspinous Fusion System, 10mm X 45mm
• B5211030100400: ZIP LP MIS Interspinous Fusion System, 10mm X 40mm
• B5211030100350: ZIP LP MIS Interspinous Fusion System, 10mm X 35mm
• B5211030080450: ZIP LP MIS Interspinous Fusion System, 8mm X 45mm
• B5211030080400: ZIP LP MIS Interspinous Fusion System, 8mm X 40mm
• B5211030080350: ZIP LP MIS Interspinous Fusion System, 8mm X 35mm
• B521001018ZIP0: ZIP ULTRA MIS Interspinous Fusion System, 18mm x 45mm
• B521001016ZIP0: ZIP ULTRA MIS Interspinous Fusion System, 16mm x 45mm
• B521001016MZIP0: ZIP ULTRA MIS Interspinous Fusion System, 16mm x 40mm
• B521001014ZIP0: ZIP ULTRA MIS Interspinous Fusion System, 14mm x 45mm
• B521001014SZIP0: ZIP ULTRA MIS Interspinous Fusion System, 14mm x 35mm
• B521001014MZIP0: ZIP ULTRA MIS Interspinous Fusion System, 14mm x 40mm
• B521001012ZIP0: ZIP ULTRA MIS Interspinous Fusion System, 12mm x 45mm
• B521001012SZIP0: ZIP ULTRA MIS Interspinous Fusion System, 12mm x 35mm
• B521001012MZIP0: ZIP ULTRA MIS Interspinous Fusion System, 12mm x 40mm
• B521001010ZIP0: ZIP ULTRA MIS Interspinous Fusion System, 10mm x 45mm
• B521001010SZIP0: ZIP ULTRA MIS Interspinous Fusion System, 10mm x 35mm
• B521001010MZIP0: ZIP ULTRA MIS Interspinous Fusion System, 10mm x 40mm
• B521001008ZIP0: ZIP ULTRA MIS Interspinous Fusion System, 8mm x 45mm
• B521001008SZIP0: ZIP ULTRA MIS Interspinous Fusion System, 8mm x 35mm
• B521001008MZIP0: ZIP ULTRA MIS Interspinous Fusion System, 8mm x 40mm
• B52100104045: ZIP All-In-One Compressor 45mm