Mediant Anterior Cervical Plate

GUDID 00814033021174

Mediant 4.0 x 12 mm Bone Screw

INTELLIGENT IMPLANT SYSTEMS, LLC

Bone-screw internal spinal fixation system, sterile Bone-screw internal spinal fixation system, sterile

• Primary Device ID: 00814033021174
• NIH Device Record Key: 6065ad27-dc12-4124-9cf7-f01a79a51b92
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mediant Anterior Cervical Plate
• Version Model Number: 1214012
• Company DUNS: 013742030
• Company Name: INTELLIGENT IMPLANT SYSTEMS, 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: true
• Expiration Date: true
• 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: 704-424-1009
• Email: info@intelligentimplantsystems.com
• Phone: 704-424-1009
• Email: info@intelligentimplantsystems.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814033021174 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173935

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: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-17

On-Brand Devices [Mediant Anterior Cervical Plate]

• 00814033021259: Mediant 4.5 x 18 mm Bone Screw
• 00814033021242: Mediant 4.5 x 16 mm Bone Screw
• 00814033021235: Mediant 4.5 x 14 mm Bone Screw
• 00814033021228: Mediant 4.5 x 12 mm Bone Screw
• 00814033021211: Mediant 4.5 x 10 mm Bone Screw
• 00814033021204: Mediant 4.0 x 18 mm Bone Screw
• 00814033021198: Mediant 4.0 x 16 mm Bone Screw
• 00814033021181: Mediant 4.0 x 14 mm Bone Screw
• 00814033021174: Mediant 4.0 x 12 mm Bone Screw
• 00814033021167: Mediant 4.0 x 10 mm Bone Screw
• 00814033021150: Mediant 78 mm plate, 3-level
• 00814033021143: Mediant 75 mm plate, 3-level
• 00814033021136: Mediant 72 mm plate, 3-level
• 00814033021129: Mediant 69 mm plate, 3-level
• 00814033021112: Mediant 66 mm plate, 3-level
• 00814033021105: Mediant 63 mm plate, 3-level
• 00814033021099: Mediant 60 mm plate, 3-level
• 00814033021082: Mediant 57 mm plate, 3-level
• 00814033021075: Mediant 54 mm plate, 3-level
• 00814033021068: Mediant 55 mm plate, 2-level
• 00814033021051: Mediant 52 mm plate, 2-level
• 00814033021044: Mediant 49 mm plate, 2-level
• 00814033021037: Mediant 46 mm plate, 2-level
• 00814033021020: Mediant 43 mm plate, 2-level
• 00814033021013: Mediant 40 mm plate, 2-level
• 00814033021006: Mediant 37 mm plate, 2-level
• 00814033020993: Mediant 36 mm plate, 1-level
• 00814033020986: Mediant 34 mm plate, 1-level
• 00814033020979: Mediant 32 mm plate, 1-level
• 00814033020962: Mediant 30 mm plate, 1-level
• 00814033020955: Mediant 28 mm plate, 1-level
• 00814033020948: Mediant 26 mm plate, 1-level
• 00814033020931: Mediant 24 mm plate, 1-level
• 00814033020924: Mediant 22 mm plate, 1-level
• 00814033020917: Mediant 20 mm plate, 1-level
• 00814033020900: Mediant 19 mm plate, 1-level