Paramount® Anterior Cervical Spine System 10-9027

GUDID 10840642129397

Pull Rod, 14 mm x 12 mm

Spine Wave, Inc.

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 10840642129397
• NIH Device Record Key: 4f715152-58cf-417a-b01c-66c07c7e533a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Paramount® Anterior Cervical Spine System
• Version Model Number: 10-9027
• Catalog Number: 10-9027
• 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: 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

Customer Support Contacts

• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com
• Phone: 203-944-9494
• Email: GUDID@spinewave.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840642129397 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173175

FDA Product Code

• OVE: Intervertebral Fusion Device With Integrated Fixation, Cervical

Sterilization

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

[10840642129397]

Moist Heat or Steam Sterilization

[10840642129397]

Moist Heat or Steam Sterilization

[10840642129397]

Moist Heat or Steam Sterilization

[10840642129397]

Moist Heat or Steam Sterilization

[10840642129397]

Moist Heat or Steam Sterilization

[10840642129397]

Moist Heat or Steam Sterilization

[10840642129397]

Moist Heat or Steam Sterilization

[10840642129397]

Moist Heat or Steam Sterilization

[10840642129397]

Moist Heat or Steam Sterilization

[10840642129397]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-23
• Device Publish Date: 2018-08-30

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

• 10840642129649: Implant Removal Tool, 14 mm x 12/13 mm
• 10840642129632: Pull Rod, 15.5 mm x 14 mm
• 10840642129403: Inserter, T-handle
• 10840642129397: Pull Rod, 14 mm x 12 mm
• 10840642129380: Modular Inserter Tip, 9/10 mm x 15.5 mm x 14 mm
• 10840642129373: Modular Inserter Tip, 7/8 mm x 15.5 mm x 14 mm
• 10840642129366: Modular Inserter Tip, 5/6 mm x 15.5 mm x 14 mm
• 10840642129359: Modular Inserter Tip, 9/10 mm x 14 mm x 12 mm
• 10840642129342: Modular Inserter Tip, 7/8 mm x 14 mm x 12 mm
• 10840642129335: Modular Inserter Tip, 5/6 mm x 14 mm x 12 mm
• 10840642129328: Implant Inserter
• 10840642149562: Implant Inserter, Wide Depth Stop
• 10840642125153: Graft Containment Plate, 10mm (H) x 15.5mm (W)
• 10840642125146: Graft Containment Plate, 9mm (H) x 15.5mm (W)
• 10840642125139: Graft Containment Plate, 8mm (H) x 15.5mm (W)
• 10840642125122: Graft Containment Plate, 7mm (H) x 15.5mm (W)
• 10840642125115: Graft Containment Plate, 6mm (H) x 15.5mm (W)
• 10840642125108: Graft Containment Plate, 5mm (H) x 15.5mm (W)
• 10840642125092: Graft Containment Plate, 10mm (H) x 14mm (W)
• 10840642125085: Graft Containment Plate, 9mm (H) x 14mm (W)
• 10840642125078: Graft Containment Plate, 8mm (H) x 14mm (W)
• 10840642125061: Graft Containment Plate, 7mm (H) x 14mm (W)
• 10840642125054: Graft Containment Plate, 6mm (H) x 14mm (W)
• 10840642125047: Graft Containment Plate, 5mm (H) x 14mm (W)
• 10840642125030: Cage and Plate Assembly, Anatomic, 8mm (H) x 15.5mm (W) x 14mm (L)
• 10840642125023: Cage and Plate Assembly, Anatomic, 7mm (H) x 15.5mm (W) x 14mm (L)
• 10840642125016: Cage and Plate Assembly, Anatomic, 6mm (H) x 15.5mm (W) x 14mm (L)
• 10840642125009: Cage and Plate Assembly, Anatomic, 5mm (H) x 15.5mm (W) x 14mm (L)
• 10840642124958: Cage and Plate Assembly, Anatomic, 8mm (H) x 14mm (W) x 12mm (L)
• 10840642124941: Cage and Plate Assembly, Anatomic, 7mm (H) x 14mm (W) x 12mm (L)
• 10840642124934: Cage and Plate Assembly, Anatomic, 6mm (H) x 14mm (W) x 12mm (L)
• 10840642124927: Cage and Plate Assembly, Anatomic, 5mm (H) x 14mm (W) x 12mm (L)
• 10840642124910: Cage and Plate Assembly, Lordotic, 10mm (H) x 15.5mm (W) x 14mm (L)
• 10840642124903: Cage and Plate Assembly, Lordotic, 9mm (H) x 15.5mm (W) x 14mm (L)
• 10840642124897: Cage and Plate Assembly, Lordotic, 8mm (H) x 15.5mm (W) x 14mm (L)
• 10840642124880: Cage and Plate Assembly, Lordotic, 7mm (H) x 15.5mm (W) x 14mm (L)
• 10840642124873: Cage and Plate Assembly, Lordotic, 6mm (H) x 15.5mm (W) x 14mm (L)
• 10840642124866: Cage and Plate Assembly, Lordotic, 5mm (H) x 15.5mm (W) x 14mm (L)
• 10840642124798: Cage and Plate Assembly, Lordotic, 10mm (H) x 14mm (W) x 12mm (L)
• 10840642124781: Cage and Plate Assembly, Lordotic, 9mm (H) x 14mm (W) x 12mm (L)
• 10840642124774: Cage and Plate Assembly, Lordotic, 8mm (H) x 14mm (W) x 12mm (L)
• 10840642124767: Cage and Plate Assembly, Lordotic, 7mm (H) x 14mm (W) x 12mm (L)
• 10840642124750: Cage and Plate Assembly, Lordotic, 6mm (H) x 14mm (W) x 12mm (L)
• 10840642124743: Cage and Plate Assembly, Lordotic, 5mm (H) x 14mm (W) x 12mm (L)