CURE OPEL-L (S)

GUDID B167900021310

MEDITECH SPINE, LLC

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable

• Primary Device ID: B167900021310
• NIH Device Record Key: 0fc2f39b-d813-4b93-8a95-509d809da5ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CURE OPEL-L (S)
• Version Model Number: 9-00021-31
• 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: 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	B167900021310 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201136

FDA Product Code

• KWQ: Appliance, fixation, spinal intervertebral body

Sterilization

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

[B167900021310]

Moist Heat or Steam Sterilization

[B167900021310]

Moist Heat or Steam Sterilization

[B167900021310]

Moist Heat or Steam Sterilization

[B167900021310]

Moist Heat or Steam Sterilization

[B167900021310]

Moist Heat or Steam Sterilization

[B167900021310]

Moist Heat or Steam Sterilization

[B167900021310]

Moist Heat or Steam Sterilization

[B167900021310]

Moist Heat or Steam Sterilization

[B167900021310]

Moist Heat or Steam Sterilization

[B167900021310]

Moist Heat or Steam Sterilization

[B167900021310]

Moist Heat or Steam Sterilization

[B167900021310]

Moist Heat or Steam Sterilization

[B167900021310]

Moist Heat or Steam Sterilization

[B167900021310]

Moist Heat or Steam Sterilization

[B167900021310]

Moist Heat or Steam Sterilization

[B167900021310]

Moist Heat or Steam Sterilization

[B167900021310]

Moist Heat or Steam Sterilization

[B167900021310]

Moist Heat or Steam Sterilization

[B167900021310]

Moist Heat or Steam Sterilization

[B167900021310]

Moist Heat or Steam Sterilization

[B167900021310]

Moist Heat or Steam Sterilization

[B167900021310]

Moist Heat or Steam Sterilization

[B167900021310]

Moist Heat or Steam Sterilization

[B167900021310]

Moist Heat or Steam Sterilization

[B167900021310]

Moist Heat or Steam Sterilization

[B167900021310]

Moist Heat or Steam Sterilization

[B167900021310]

Moist Heat or Steam Sterilization

[B167900021310]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-17
• Device Publish Date: 2022-10-07

On-Brand Devices [CURE OPEL-L (S)]

• B167S1900021450: S1-9-00021-45
• B167S1900021440: S1-9-00021-44
• B167S1900021430: S1-9-00021-43
• B167S1900021420: S1-9-00021-42
• B167S1900021410: S1-9-00021-41
• B167S1900021400: S1-9-00021-40
• B167S1900021390: S1-9-00021-39
• B167S1900021380: S1-9-00021-38
• B167S1900021370: S1-9-00021-37
• B167S1900021360: S1-9-00021-36
• B167S1900021350: S1-9-00021-35
• B167S1900021340: S1-9-00021-34
• B167S1900021330: S1-9-00021-33
• B167S1900021320: S1-9-00021-32
• B167S1900021310: S1-9-00021-31
• B167S1900021300: S1-9-00021-30
• B167S1900021290: S1-9-00021-29
• B167S1900021280: S1-9-00021-28
• B167S1900021270: S1-9-00021-27
• B167S1900021260: S1-9-00021-26
• B167S1900021250: S1-9-00021-25
• B167900021450: 9-00021-45
• B167900021440: 9-00021-44
• B167900021430: 9-00021-43
• B167900021420: 9-00021-42
• B167900021410: 9-00021-41
• B167900021400: 9-00021-40
• B167900021390: 9-00021-39
• B167900021380: 9-00021-38
• B167900021370: 9-00021-37
• B167900021360: 9-00021-36
• B167900021350: 9-00021-35
• B167900021340: 9-00021-34
• B167900021330: 9-00021-33
• B167900021320: 9-00021-32
• B167900021310: 9-00021-31
• B167900021300: 9-00021-30
• B167900021290: 9-00021-29
• B167900021280: 9-00021-28
• B167900021270: 9-00021-27
• B167900021260: 9-00021-26
• B167900021250: 9-00021-25
• B167900909160: 900-909-16