Blade® Anterior Cervical Plate System

GUDID 00889929000335

Cervical Plate, 3 Level 48mm

NEXXT SPINE, LLC

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00889929000335
• NIH Device Record Key: 6e4af615-44ee-4cb4-9848-832c05473eee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blade® Anterior Cervical Plate System
• Version Model Number: 30-3-48
• Company DUNS: 003489810
• Company Name: NEXXT SPINE, LLC
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com
• Phone: 317-436-7801
• Email: Support@nexxtspine.com

Device Dimensions

• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 48 Millimeter
• Device Size Text, specify: 0
• Length: 48 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889929000335 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091936

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[00889929000335]

Moist Heat or Steam Sterilization

[00889929000335]

Moist Heat or Steam Sterilization

[00889929000335]

Moist Heat or Steam Sterilization

[00889929000335]

Moist Heat or Steam Sterilization

[00889929000335]

Moist Heat or Steam Sterilization

[00889929000335]

Moist Heat or Steam Sterilization

[00889929000335]

Moist Heat or Steam Sterilization

[00889929000335]

Moist Heat or Steam Sterilization

[00889929000335]

Moist Heat or Steam Sterilization

[00889929000335]

Moist Heat or Steam Sterilization

[00889929000335]

Moist Heat or Steam Sterilization

[00889929000335]

Moist Heat or Steam Sterilization

[00889929000335]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-09-18
• Device Publish Date: 2015-07-29

On-Brand Devices [Blade® Anterior Cervical Plate System]

• 00889929011157: Blade Plate Caddy, 3 Level
• 00889929011140: Blade Plate Caddy, 1-2 Level
• 00889929011133: Blade Screw Caddy
• 00889929011126: Blade Case
• 00889929000625: Rescue Screw, Self Drilling, Ø4.35 x 20mm
• 00889929000618: Rescue Screw, Self Drilling, Ø4.35 x 18mm
• 00889929000601: Rescue Screw, Self Drilling, Ø4.35 x 16mm
• 00889929000595: Rescue Screw, Self Drilling, Ø4.35 x 14mm
• 00889929000588: Rescue Screw, Self Drilling, Ø4.35 x 12mm
• 00889929000571: Rescue Screw, Self Drilling, Ø4.35 x 10mm
• 00889929000564: Screw, Self Drilling, Ø4.0 x 20mm
• 00889929000557: Screw, Self Drilling, Ø4.0 x 18mm
• 00889929000540: Screw, Self Drilling, Ø4.0 x 16mm
• 00889929000533: Screw, Self Drilling, Ø4.0 x 14mm
• 00889929000526: Screw, Self Drilling, Ø4.0 x 12mm
• 00889929000519: Screw, Self Drilling, Ø4.0 x 10mm
• 00889929000502: Cervical Plate, 4 Level 96mm
• 00889929000496: Cervical Plate, 4 Level 92mm
• 00889929000489: Cervical Plate, 4 Level 88mm
• 00889929000472: Cervical Plate, 4 Level 84mm
• 00889929000465: Cervical Plate, 4 Level 80mm
• 00889929000458: Cervical Plate, 4 Level 76mm
• 00889929000441: Cervical Plate, 4 Level 72mm
• 00889929000434: Cervical Plate, 4 Level 68mm
• 00889929000427: Cervical Plate, 3 Level 75mm
• 00889929000410: Cervical Plate, 3 Level 72mm
• 00889929000403: Cervical Plate, 3 Level 69mm
• 00889929000397: Cervical Plate, 3 Level 66mm
• 00889929000380: Cervical Plate, 3 Level 63mm
• 00889929000373: Cervical Plate, 3 Level 60mm
• 00889929000366: Cervical Plate, 3 Level 57mm
• 00889929000359: Cervical Plate, 3 Level 54mm
• 00889929000342: Cervical Plate, 3 Level 51mm
• 00889929000335: Cervical Plate, 3 Level 48mm
• 00889929000328: Cervical Plate, 2 Level 54mm
• 00889929000311: Cervical Plate, 2 Level 52mm
• 00889929000304: Cervical Plate, 2 Level 50mm
• 00889929000298: Cervical Plate, 2 Level 48mm
• 00889929000281: Cervical Plate, 2 Level 46mm
• 00889929000274: Cervical Plate, 2 Level 44mm
• 00889929000267: Cervical Plate, 2 Level 42mm
• 00889929000250: Cervical Plate, 2 Level 40mm
• 00889929000243: Cervical Plate, 2 Level 38mm
• 00889929000236: Cervical Plate, 2 Level 36mm
• 00889929000229: Cervical Plate, 2 Level 34mm
• 00889929000212: Cervical Plate, 1 Level 36mm
• 00889929000205: Cervical Plate, 1 Level 34mm
• 00889929000199: Cervical Plate, 1 Level 32mm
• 00889929000182: Cervical Plate, 1 Level 30mm
• 00889929000175: Cervical Plate, 1 Level 28mm