Apollo Anterior Cervical Plate System

GUDID B521115001140

Apollo Plate 1 Level 14mm

AURORA SPINE, INC.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: B521115001140
• NIH Device Record Key: 5edc9d3e-6969-47d1-9243-36e3d0e39494
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Apollo Anterior Cervical Plate System
• Version Model Number: 115-001-14
• Company DUNS: 079119091
• Company Name: AURORA SPINE, INC.
• Device Count: 1
• DM Exempt: false
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 760-424-2004
• Email: info@auroraspine.us
• Phone: 760-424-2004
• Email: info@auroraspine.us
• Phone: 760-424-2004
• Email: info@auroraspine.us
• Phone: 760-424-2004
• Email: info@auroraspine.us
• Phone: 760-424-2004
• Email: info@auroraspine.us
• Phone: 760-424-2004
• Email: info@auroraspine.us
• Phone: 760-424-2004
• Email: info@auroraspine.us
• Phone: 760-424-2004
• Email: info@auroraspine.us
• Phone: 760-424-2004
• Email: info@auroraspine.us
• Phone: 760-424-2004
• Email: info@auroraspine.us
• Phone: 760-424-2004
• Email: info@auroraspine.us
• Phone: 760-424-2004
• Email: info@auroraspine.us
• Phone: 760-424-2004
• Email: info@auroraspine.us
• Phone: 760-424-2004
• Email: info@auroraspine.us
• Phone: 760-424-2004
• Email: info@auroraspine.us
• Phone: 760-424-2004
• Email: info@auroraspine.us
• Phone: 760-424-2004
• Email: info@auroraspine.us

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B521115001140 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210325

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[B521115001140]

Moist Heat or Steam Sterilization

[B521115001140]

Moist Heat or Steam Sterilization

[B521115001140]

Moist Heat or Steam Sterilization

[B521115001140]

Moist Heat or Steam Sterilization

[B521115001140]

Moist Heat or Steam Sterilization

[B521115001140]

Moist Heat or Steam Sterilization

[B521115001140]

Moist Heat or Steam Sterilization

[B521115001140]

Moist Heat or Steam Sterilization

[B521115001140]

Moist Heat or Steam Sterilization

[B521115001140]

Moist Heat or Steam Sterilization

[B521115001140]

Moist Heat or Steam Sterilization

[B521115001140]

Moist Heat or Steam Sterilization

[B521115001140]

Moist Heat or Steam Sterilization

[B521115001140]

Moist Heat or Steam Sterilization

[B521115001140]

Moist Heat or Steam Sterilization

[B521115001140]

Moist Heat or Steam Sterilization

[B521115001140]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-21
• Device Publish Date: 2024-08-13

On-Brand Devices [Apollo Anterior Cervical Plate System]

• B52111560002040: Apollo Rack Plate Cover
• B52111560002030: Apollo Rack Plates
• B52111560002020: Apollo Rack Screw Cover
• B52111560002010: Apollo Rack Screws
• B521115600020: Apollo Implant Tray
• B521115312010: Apollo Retaining Driver AO Connect Shaft
• B52111530930100: Apollo Tap Ø3.0mm x 10mm
• B521115307160: Apollo Drill Bit 16mm
• B521115307140: Apollo Drill Bit 14mm
• B521115307120: Apollo Drill Bit 12mm
• B521115307100: Apollo Drill Bit 10mm
• B521115306060: Apollo Single Drill Tower Variable Angle
• B521115306050: Apollo Single Drill Guide Variable Angle
• B521115305010: Apollo Awl Straight
• B521115304020: Apollo Pin Holder
• B521115304010: Apollo Temporary Fixation Pin Smooth
• B521115302010: Apollo Plate Holder
• B521115006SDVA45180: Apollo Screw Self-Drilling Variable Ø4.5mm x 18mm
• B521115006SDVA45160: Apollo Screw Self-Drilling Variable Ø4.5mm x 16mm
• B521115006SDVA45140: Apollo Screw Self-Drilling Variable Ø4.5mm x 14mm
• B521115006SDVA45120: Apollo Screw Self-Drilling Variable Ø4.5mm x 12mm
• B521115006SDVA40180: Apollo Screw Self-Drilling Variable Ø4.0mm x 18mm
• B521115006SDVA40160: Apollo Screw Self-Drilling Variable Ø4.0mm x 16mm
• B521115006SDVA40140: Apollo Screw Self-Drilling Variable Ø4.0mm x 14mm
• B521115006SDVA40120: Apollo Screw Self-Drilling Variable Ø4.0mm x 12mm
• B521115006SDFA45180: Apollo Screw Self-Drilling Fixed Ø4.5mm x 18mm
• B521115006SDFA45160: Apollo Screw Self-Drilling Fixed Ø4.5mm x 16mm
• B521115006SDFA45140: Apollo Screw Self-Drilling Fixed Ø4.5mm x 14mm
• B521115006SDFA45120: Apollo Screw Self-Drilling Fixed Ø4.5mm x 12mm
• B521115006SDFA40180: Apollo Screw Self-Drilling Fixed Ø4.0mm x 18mm
• B521115006SDFA40160: Apollo Screw Self-Drilling Fixed Ø4.0mm x 16mm
• B521115006SDFA40140: Apollo Screw Self-Drilling Fixed Ø4.0mm x 14mm
• B521115006SDFA40120: Apollo Screw Self-Drilling Fixed Ø4.0mm x 12mm
• B521115003630: Apollo Plate 3 Level 63mm
• B521115003600: Apollo Plate 3 Level 60mm
• B521115003570: Apollo Plate 3 Level 57mm
• B521115003540: Apollo Plate 3 Level 54mm
• B521115003510: Apollo Plate 3 Level 51mm
• B521115003480: Apollo Plate 3 Level 48mm
• B521115003450: Apollo Plate 3 Level 45mm
• B521115003420: Apollo Plate 3 Level 42mm
• B521115003390: Apollo Plate 3 Level 39mm
• B521115002420: Apollo Plate 2 Level 42mm
• B521115002400: Apollo Plate 2 Level 40mm
• B521115002380: Apollo Plate 2 Level 38mm
• B521115002360: Apollo Plate 2 Level 36mm
• B521115002340: Apollo Plate 2 Level 34mm
• B521115002320: Apollo Plate 2 Level 32mm
• B521115002300: Apollo Plate 2 Level 30mm
• B521115002280: Apollo Plate 2 Level 28mm