CURE IVIEW

GUDID B167S1900002380

MEDITECH SPINE, LLC

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: B167S1900002380
• NIH Device Record Key: cbf9c9f5-0ad7-4131-9cc3-eb55445ee265
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CURE IVIEW
• Version Model Number: S1-9-00002-38
• Company DUNS: 182698477
• Company Name: MEDITECH 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: true
• 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	B167S1900002380 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180090

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: 2022-10-14
• Device Publish Date: 2022-10-06

On-Brand Devices [CURE IVIEW]

• B167S1900002450: S1-9-00002-45
• B167S1900002440: S1-9-00002-44
• B167S1900002430: S1-9-00002-43
• B167S1900002420: S1-9-00002-42
• B167S1900002410: S1-9-00002-41
• B167S1900002400: S1-9-00002-40
• B167S1900002390: S1-9-00002-39
• B167S1900002380: S1-9-00002-38
• B167S1900002370: S1-9-00002-37
• B167S1900002360: S1-9-00002-36
• B167S1900002350: S1-9-00002-35
• B167S1900002340: S1-9-00002-34
• B167S1900002330: S1-9-00002-33
• B167S1900002320: S1-9-00002-32
• B167S1900002310: S1-9-00002-31
• B167S1900002300: S1-9-00002-30
• B167S1900002290: S1-9-00002-29
• B167S1900002280: S1-9-00002-28
• B167S1900002270: S1-9-00002-27
• B167S1900002260: S1-9-00002-26
• B167S1900002250: S1-9-00002-25
• B167900002450: 9-00002-45
• B167900002440: 9-00002-44
• B167900002430: 9-00002-43
• B167900002420: 9-00002-42
• B167900002410: 9-00002-41
• B167900002400: 9-00002-40
• B167900002390: 9-00002-39
• B167900002380: 9-00002-38
• B167900002370: 9-00002-37
• B167900002360: 9-00002-36
• B167900002350: 9-00002-35
• B167900002340: 9-00002-34
• B167900002330: 9-00002-33
• B167900002320: 9-00002-32
• B167900002310: 9-00002-31
• B167900002300: 9-00002-30
• B167900002290: 9-00002-29
• B167900002280: 9-00002-28
• B167900002270: 9-00002-27
• B167900002260: 9-00002-26
• B167900002250: 9-00002-25