Spinema Lumbar Plate System 5326-4054S

GUDID 00840273301974

Lumbar Plate 3 Hole 54mm

Aegis Spine, Inc.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00840273301974
• NIH Device Record Key: df5ca659-1ae0-4f46-8d28-31d0607b7da3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spinema Lumbar Plate System
• Version Model Number: 5326-4054S
• Catalog Number: 5326-4054S
• Company DUNS: 017993061
• Company Name: Aegis 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840273301974 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210035

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-21
• Device Publish Date: 2021-09-13

On-Brand Devices [Spinema Lumbar Plate System]

• 00840273301806: Lumbar Plate 2 Hole 38mm
• 00840273301790: Lumbar Plate 2 Hole 36mm
• 00840273301783: Lumbar Plate 2 Hole 34mm
• 00840273301776: Lumbar Plate 2 Hole 32mm
• 00840273301769: Lumbar Plate 2 Hole 48mm
• 00840273301752: Lumbar Plate 2 Hole 46mm
• 00840273301745: Lumbar Plate 2 Hole 44mm
• 00840273301738: Lumbar Plate 2 Hole 42mm
• 00840273301721: Lumbar Plate 2 Hole 40mm
• 00840273301714: Lumbar Plate 2 Hole 38mm
• 00840273301707: Lumbar Plate 2 Hole 36mm
• 00840273301691: Lumbar Plate 2 Hole 34mm
• 00840273301684: Lumbar Plate 2 Hole 32mm
• 00840273302599: Variable Lumbar Plate Screw Dual Thread Ø 5.5x 45mm
• 00840273302582: Variable Lumbar Plate Screw Dual Thread Ø 5.5x 40mm
• 00840273302575: Variable Lumbar Plate Screw Dual Thread Ø 5.5x 35mm
• 00840273302568: Variable Lumbar Plate Screw Dual Thread Ø 5.5x 30mm
• 00840273302551: Variable Lumbar Plate Screw Dual Thread Ø 5.5x 25mm
• 00840273302544: Variable Lumbar Plate Screw Dual Thread Ø 5.5x 20mm
• 00840273302537: Fixed Lumbar Plate Screw Cancellous Ø 6.0x 55mm
• 00840273302520: Fixed Lumbar Plate Screw Cancellous Ø 6.0x 50mm
• 00840273302513: Fixed Lumbar Plate Screw Cancellous Ø 6.0x 45mm
• 00840273302506: Fixed Lumbar Plate Screw Cancellous Ø 6.0x 40mm
• 00840273302490: Fixed Lumbar Plate Screw Cancellous Ø 6.0x 35mm
• 00840273302483: Fixed Lumbar Plate Screw Cancellous Ø 6.0x 30mm
• 00840273302476: Fixed Lumbar Plate Screw Cancellous Ø 6.0x 25mm
• 00840273302469: Fixed Lumbar Plate Screw Cancellous Ø 6.0x 20mm
• 00840273302452: Fixed Lumbar Plate Screw Cancellous Ø 5.5x 55mm
• 00840273302445: Fixed Lumbar Plate Screw Cancellous Ø 5.5x 50mm
• 00840273302438: Fixed Lumbar Plate Screw Cancellous Ø 5.5x 45mm
• 00840273302421: Fixed Lumbar Plate Screw Cancellous Ø 5.5x 40mm
• 00840273302414: Fixed Lumbar Plate Screw Cancellous Ø 5.5x 35mm
• 00840273302407: Fixed Lumbar Plate Screw Cancellous Ø 5.5x 30mm
• 00840273302391: Fixed Lumbar Plate Screw Cancellous Ø 5.5x 25mm
• 00840273302384: Fixed Lumbar Plate Screw Cancellous Ø 5.5x 20mm
• 00840273302377: Fixed Lumbar Plate Screw Dual Thread Ø 6.0x 55mm
• 00840273302360: Fixed Lumbar Plate Screw Dual Thread Ø 6.0x 50mm
• 00840273302353: Fixed Lumbar Plate Screw Dual Thread Ø 6.0x 45mm
• 00840273302346: Fixed Lumbar Plate Screw Dual Thread Ø 6.0x 40mm
• 00840273302339: Fixed Lumbar Plate Screw Dual Thread Ø 6.0x 35mm
• 00840273302322: Fixed Lumbar Plate Screw Dual Thread Ø 6.0x 30mm
• 00840273302315: Fixed Lumbar Plate Screw Dual Thread Ø 6.0x 25mm
• 00840273302308: Fixed Lumbar Plate Screw Dual Thread Ø 6.0x 20mm
• 00840273302292: Fixed Lumbar Plate Screw Dual Thread Ø 5.5x 55mm
• 00840273302285: Fixed Lumbar Plate Screw Dual Thread Ø 5.5x 50mm
• 00840273302278: Fixed Lumbar Plate Screw Dual Thread Ø 5.5x 45mm
• 00840273302261: Fixed Lumbar Plate Screw Dual Thread Ø 5.5x 40mm
• 00840273302254: Fixed Lumbar Plate Screw Dual Thread Ø 5.5x 35mm
• 00840273302247: Fixed Lumbar Plate Screw Dual Thread Ø 5.5x 30mm
• 00840273302230: Fixed Lumbar Plate Screw Dual Thread Ø 5.5x 25mm