Cervical Plate 100065-0

GUDID B5231000650

Lock Cover Driver

Eisertech, LLC

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: B5231000650
• NIH Device Record Key: 736cf179-1331-45c5-a6c2-e53787d8d7fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cervical Plate
• Version Model Number: 100065-0
• Catalog Number: 100065-0
• Company DUNS: 965627297
• Company Name: Eisertech, 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: 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B5231000650 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113170

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[B5231000650]

Moist Heat or Steam Sterilization

[B5231000650]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-04-07

On-Brand Devices [Cervical Plate]

• B5231001670: Variable Awl
• B5231001630: Fixed Awl
• B5231000944516: Fixed Screw, 4.5mm x 16mm L
• B5231000944514: Fixed Screw, 4.5mm x 14mm L
• B5231000944512: Fixed Screw, 4.5mm x 12mm L
• B5231000944510: Fixed Screw, 4.5mm x 10mm L
• B5231000944016: Fixed Screw, 4.0mm x 16mm L
• B5231000944014: Fixed Screw, 4.0mm x 14mm L
• B5231000944012: Fixed Screw, 4.0mm x 12mm L
• B5231000944010: Fixed Screw, 4.0mm x 10mm L
• B5231000934516: Variable Screw, 4.5mm x 16mm L
• B5231000934514: Variable Screw, 4.5mm x 14mm L
• B5231000934512: Variable Screw, 4.5mm x 12mm L
• B5231000934510: Variable Screw, 4.5mm x 10mm L
• B5231000934016: Variable Screw, 4.0mm x 16mm L
• B5231000934014: Variable Screw, 4.0mm x 14mm L
• B5231000934012: Variable Screw, 4.0mm x 12mm L
• B5231000934010: Variable Screw, 4.0mm x 10mm L
• B52310009098: Cervical Plate - 4 Level x 98mm
• B52310009094: Cervical Plate - 4 Level x 94mm
• B52310009090: Cervical Plate - 4 Level x 90mm
• B52310009086: Cervical Plate - 4 Level x 86mm
• B52310009082: Cervical Plate - 4 Level x 82mm
• B52310009078: Cervical Plate - 4 Level x 78mm
• B52310009074: Cervical Plate - 4 Level x 74mm
• B52310009070: Cervical Plate - 4 Level x 70mm
• B523100090110: Cervical Plate - 4 Level x 110mm
• B523100090106: Cervical Plate - 4 Level x 106mm
• B523100090102: Cervical Plate - 4 Level x 102mm
• B52310008978: Cervical Plate - 3 Level x 78mm
• B52310008975: Cervical Plate - 3 Level x 75mm
• B52310008972: Cervical Plate - 3 Level x 72mm
• B52310008969: Cervical Plate - 3 Level x 69mm
• B52310008966: Cervical Plate - 3 Level x 66mm
• B52310008963: Cervical Plate - 3 Level x 63mm
• B52310008960: Cervical Plate - 3 Level x 60mm
• B52310008957: Cervical Plate - 3 Level x 57mm
• B52310008954: Cervical Plate - 3 Level x 54mm
• B52310008852: Cervical Plate - 2 Level x 52mm
• B52310008850: Cervical Plate - 2 Level x 50mm
• B52310008848: Cervical Plate - 2 Level x 48mm
• B52310008846: 100088-46
• B52310008844: Cervical Plate - 2 Level x 44mm
• B52310008842: Cervical Plate - 2 Level x 42mm
• B52310008840: Cervical Plate - 2 Level x 40mm
• B52310008838: Cervical Plate - 2 Level x 38mm
• B52310008736: Cervical Plate, 1 Level, 36mm
• B52310008734: Cervical Plate, 1 Level, 34mm
• B52310008732: Cervical Plate, 1 Level, 32mm
• B52310008730: Cervical Plate, 1 Level, 30mm