CURE OPEL-L

GUDID B16790044228T0

MEDITECH SPINE, LLC

General internal orthopaedic fixation system implantation kit

• Primary Device ID: B16790044228T0
• NIH Device Record Key: 62af93e5-fa7f-496d-9ead-23cddff2eb0f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CURE OPEL-L
• Version Model Number: 900-442-28-T
• 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: 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	B16790044228T0 [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

[B16790044228T0]

Moist Heat or Steam Sterilization

[B16790044228T0]

Moist Heat or Steam Sterilization

[B16790044228T0]

Moist Heat or Steam Sterilization

[B16790044228T0]

Moist Heat or Steam Sterilization

[B16790044228T0]

Moist Heat or Steam Sterilization

[B16790044228T0]

Moist Heat or Steam Sterilization

[B16790044228T0]

Moist Heat or Steam Sterilization

[B16790044228T0]

Moist Heat or Steam Sterilization

[B16790044228T0]

Moist Heat or Steam Sterilization

[B16790044228T0]

Moist Heat or Steam Sterilization

[B16790044228T0]

Moist Heat or Steam Sterilization

[B16790044228T0]

Moist Heat or Steam Sterilization

[B16790044228T0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-14
• Device Publish Date: 2022-10-06

On-Brand Devices [CURE OPEL-L]

• B16790044245T0: 900-442-45-T
• B16790044244T0: 900-442-44-T
• B16790044243T0: 900-442-43-T
• B16790044242T0: 900-442-42-T
• B16790044241T0: 900-442-41-T
• B16790044240T0: 900-442-40-T
• B16790044239T0: 900-442-39-T
• B16790044238T0: 900-442-38-T
• B16790044237T0: 900-442-37-T
• B16790044236T0: 900-442-36-T
• B16790044235T0: 900-442-35-T
• B16790044234T0: 900-442-34-T
• B16790044233T0: 900-442-33-T
• B16790044232T0: 900-442-32-T
• B16790044231T0: 900-442-31-T
• B16790044230T0: 900-442-30-T
• B16790044229T0: 900-442-29-T
• B16790044228T0: 900-442-28-T
• B16790044227T0: 900-442-27-T
• B16790044226T0: 900-442-26-T
• B16790044225T0: 900-442-25-T
• B16790042900020: 900-429-00-02
• B16790042900010: 900-429-00-01
• B167900429000: 900-429-00
• B16790042145T0: 900-421-45-T
• B16790042144T0: 900-421-44-T
• B16790042143T0: 900-421-43-T
• B16790042142T0: 900-421-42-T
• B16790042141T0: 900-421-41-T
• B16790042140T0: 900-421-40-T
• B16790042139T0: 900-421-39-T
• B16790042138T0: 900-421-38-T
• B16790042137T0: 900-421-37-T
• B16790042136T0: 900-421-36-T
• B16790042135T0: 900-421-35-T
• B16790042134T0: 900-421-34-T
• B16790042133T0: 900-421-33-T
• B16790042132T0: 900-421-32-T
• B16790042131T0: 900-421-31-T
• B16790042130T0: 900-421-30-T
• B16790042129T0: 900-421-29-T
• B16790042128T0: 900-421-28-T
• B16790042127T0: 900-421-27-T
• B16790042126T0: 900-421-26-T
• B16790042125T0: 900-421-25-T
• B16790042100T0: 900-421-00-T
• B1679004210001T0: 900-421-00-01-T