CURE OPEL-L

GUDID B16790042131T0

MEDITECH SPINE, LLC

General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit

• Primary Device ID: B16790042131T0
• NIH Device Record Key: 45da4901-5e3c-45ac-a10b-1a58b56b26fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CURE OPEL-L
• Version Model Number: 900-421-31-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	B16790042131T0 [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

[B16790042131T0]

Moist Heat or Steam Sterilization

[B16790042131T0]

Moist Heat or Steam Sterilization

[B16790042131T0]

Moist Heat or Steam Sterilization

[B16790042131T0]

Moist Heat or Steam Sterilization

[B16790042131T0]

Moist Heat or Steam Sterilization

[B16790042131T0]

Moist Heat or Steam Sterilization

[B16790042131T0]

Moist Heat or Steam Sterilization

[B16790042131T0]

Moist Heat or Steam Sterilization

[B16790042131T0]

Moist Heat or Steam Sterilization

[B16790042131T0]

Moist Heat or Steam Sterilization

[B16790042131T0]

Moist Heat or Steam Sterilization

[B16790042131T0]

Moist Heat or Steam Sterilization

[B16790042131T0]

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