Paramount™ Anterior Cervical Spine System 10-5616

GUDID 10840642119053

Anatomic Scoring Trial, 6 mm x 15.5 mm x 14 mm

Spine Wave, Inc.

Polymeric spinal interbody fusion cage

• Primary Device ID: 10840642119053
• NIH Device Record Key: 739aa9c4-3d9e-4de4-93e1-6a40b26dd4b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Paramount™ Anterior Cervical Spine System
• Version Model Number: 10-5616
• Catalog Number: 10-5616
• Company DUNS: 067789763
• Company Name: Spine Wave, 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840642119053 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162760

FDA Product Code

• OVE: Intervertebral Fusion Device With Integrated Fixation, Cervical

Sterilization

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

[10840642119053]

Moist Heat or Steam Sterilization

[10840642119053]

Moist Heat or Steam Sterilization

[10840642119053]

Moist Heat or Steam Sterilization

[10840642119053]

Moist Heat or Steam Sterilization

[10840642119053]

Moist Heat or Steam Sterilization

[10840642119053]

Moist Heat or Steam Sterilization

[10840642119053]

Moist Heat or Steam Sterilization

[10840642119053]

Moist Heat or Steam Sterilization

[10840642119053]

Moist Heat or Steam Sterilization

[10840642119053]

Moist Heat or Steam Sterilization

[10840642119053]

Moist Heat or Steam Sterilization

[10840642119053]

Moist Heat or Steam Sterilization

[10840642119053]

Moist Heat or Steam Sterilization

[10840642119053]

Moist Heat or Steam Sterilization

[10840642119053]

Moist Heat or Steam Sterilization

[10840642119053]

Moist Heat or Steam Sterilization

[10840642119053]

Moist Heat or Steam Sterilization

[10840642119053]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2017-09-21

On-Brand Devices [Paramount™ Anterior Cervical Spine System]

• 10840642121063: Anatomic Scoring Trial, 8 mm x 14 mm x 12 mm
• 10840642121056: Anatomic Scoring Trial, 7 mm x 14 mm x 12 mm
• 10840642121049: Anatomic Scoring Trial, 6 mm x 14 mm x 12 mm
• 10840642121032: Anatomic Scoring Trial, 5 mm x 14 mm x 12 mm
• 10840642121025: Lordotic Scoring Trial, 10 mm x 14 mm x 12 mm
• 10840642121018: Lordotic Scoring Trial, 9 mm x 14 mm x 12 mm
• 10840642121001: Lordotic Scoring Trial, 8 mm x 14 mm x 12 mm
• 10840642120998: Lordotic Scoring Trial, 7 mm x 14 mm x 12 mm
• 10840642120981: Lordotic Scoring Trial, 6 mm x 14 mm x 12 mm
• 10840642120974: Lordotic Scoring Trial, 5 mm x 14 mm x 12 mm
• 10840642120967: Lordotic Scoring Trial, 10 mm x 15.5 mm x 14 mm
• 10840642120950: Lordotic Scoring Trial, 9 mm x 15.5 mm x 14 mm
• 10840642120943: Lordotic Scoring Trial, 8 mm x 15.5 mm x 14 mm
• 10840642120936: Lordotic Scoring Trial, 7 mm x 15.5 mm x 14 mm
• 10840642120929: Lordotic Scoring Trial, 6 mm x 15.5 mm x 14 mm
• 10840642120912: Lordotic Scoring Trial, 5 mm x 15.5 mm x 14 mm
• 10840642119060: Anatomic Scoring Trial, 5 mm x 15.5 mm x 14 mm
• 10840642119053: Anatomic Scoring Trial, 6 mm x 15.5 mm x 14 mm
• 10840642119046: Anatomic Scoring Trial, 7 mm x 15.5 mm x 14 mm
• 10840642119039: Anatomic Scoring Trial, 8 mm x 15.5 mm x 14 mm
• 10840642111996: Plunger, Implant Removal Tool
• 10840642111989: Implant Removal Tool, 15.5 mm x 14 mm
• 10840642111972: Implant Removal Tool, 14 mm x 13 mm
• 10840642111866: Anatomic Scoring Trial, 8 mm x 14 mm x 13 mm
• 10840642111859: Anatomic Scoring Trial, 7 mm x 14 mm x 13 mm
• 10840642111842: Anatomic Scoring Trial, 6 mm x 14 mm x 13 mm
• 10840642111835: Anatomic Scoring Trial, 5 mm x 14 mm x 13 mm
• 10840642111828: Lordotic Scoring Trial, 10 mm x 14 mm x 13 mm
• 10840642111811: Lordotic Scoring Trial, 9 mm x 14 mm x 13 mm
• 10840642111804: Lordotic Scoring Trial, 8 mm x 14 mm x 13 mm
• 10840642111798: Lordotic Scoring Trial, 7 mm x 14 mm x 13 mm
• 10840642111781: Lordotic Scoring Trial, 6 mm x 14 mm x 13 mm
• 10840642111774: Lordotic Scoring Trial, 5 mm x 14 mm x 13 mm
• 10840642111767: Anchor Plate Pull Rod
• 10840642111750: Implant Inserter, 9/10 mm x 15.5 mm x 14 mm
• 10840642111743: Implant Inserter, 7/8 mm x 15.5 mm x 14 mm
• 10840642111736: Implant Inserter, 5/6 mm x 15.5 mm x 14 mm
• 10840642111729: Implant Inserter, 9/10 mm x 14 mm x 13 mm
• 10840642111712: Implant Inserter, 7/8 mm x 14 mm x 13 mm
• 10840642111705: Implant Inserter, 5/6 mm x 14 mm x 13 mm
• 10840642111699: Graft Containment Plate, Anatomic, 8 mm (H) x 15.5 mm (W)
• 10840642111682: Graft Containment Plate, Anatomic, 7 mm (H) x 15.5 mm (W)
• 10840642111675: Graft Containment Plate, Anatomic, 6 mm (H) x 15.5 mm (W)
• 10840642111668: Graft Containment Plate, Anatomic, 5 mm (H) x 15.5 mm (W)
• 10840642111651: Graft Containment Plate, Anatomic, 8 mm (H) x 14 mm (W)
• 10840642111644: Graft Containment Plate, Anatomic, 7 mm (H) x 14 mm (W)
• 10840642111637: Graft Containment Plate, Anatomic, 6 mm (H) x 14 mm (W)
• 10840642111620: Graft Containment Plate, Anatomic, 5 mm (H) x 14 mm (W)
• 10840642111613: Graft Containment Plate, Lordotic, 10 mm (H) x 15.5 mm (W)
• 10840642111606: Graft Containment Plate, Lordotic, 9 mm (H) x 15.5 mm (W)