OPEL-C

GUDID B16711004220S0

MEDITECH SPINE, LLC

General internal orthopaedic fixation system implantation kit

• Primary Device ID: B16711004220S0
• NIH Device Record Key: e0ab5daa-ef82-45e7-9807-fb0f98256155
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPEL-C
• Version Model Number: 1100-422-0S
• 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: false
• Lot Batch: true
• Serial Number: true
• 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	B16711004220S0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160604

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[B16711004220S0]

Moist Heat or Steam Sterilization

[B16711004220S0]

Moist Heat or Steam Sterilization

[B16711004220S0]

Moist Heat or Steam Sterilization

[B16711004220S0]

Moist Heat or Steam Sterilization

[B16711004220S0]

Moist Heat or Steam Sterilization

[B16711004220S0]

Moist Heat or Steam Sterilization

[B16711004220S0]

Moist Heat or Steam Sterilization

[B16711004220S0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-27
• Device Publish Date: 2022-06-17

On-Brand Devices [OPEL-C]

• B16711004220S0: 1100-422-0S
• B16711004120S0: 1100-412-0S