SpineSmith Cimplicity Spinal System 0100-0001-PL

GUDID 00817771020003

Celling Biosciences

Polymeric spinal interbody fusion cage

• Primary Device ID: 00817771020003
• NIH Device Record Key: eb801687-1d86-4bf7-96fd-b73f758b5111
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpineSmith Cimplicity Spinal System
• Version Model Number: Cimplicity Stopped System Kit
• Catalog Number: 0100-0001-PL
• Company DUNS: 021560394
• Company Name: Celling Biosciences
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817771020003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073320

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

[00817771020003]

Moist Heat or Steam Sterilization

[00817771020003]

Moist Heat or Steam Sterilization

[00817771020003]

Moist Heat or Steam Sterilization

[00817771020003]

Moist Heat or Steam Sterilization

[00817771020003]

Moist Heat or Steam Sterilization

[00817771020003]

Moist Heat or Steam Sterilization

[00817771020003]

Moist Heat or Steam Sterilization

[00817771020003]

Moist Heat or Steam Sterilization

[00817771020003]

Moist Heat or Steam Sterilization

[00817771020003]

Moist Heat or Steam Sterilization

[00817771020003]

Moist Heat or Steam Sterilization

[00817771020003]

Moist Heat or Steam Sterilization

[00817771020003]

Moist Heat or Steam Sterilization

[00817771020003]

Moist Heat or Steam Sterilization

[00817771020003]

Moist Heat or Steam Sterilization

[00817771020003]

Moist Heat or Steam Sterilization

[00817771020003]

Moist Heat or Steam Sterilization

[00817771020003]

Moist Heat or Steam Sterilization

[00817771020003]

Moist Heat or Steam Sterilization

[00817771020003]

Moist Heat or Steam Sterilization

[00817771020003]

Moist Heat or Steam Sterilization

[00817771020003]

Moist Heat or Steam Sterilization

[00817771020003]

Moist Heat or Steam Sterilization

[00817771020003]

Moist Heat or Steam Sterilization

[00817771020003]

Moist Heat or Steam Sterilization

[00817771020003]

Moist Heat or Steam Sterilization

[00817771020003]

Moist Heat or Steam Sterilization

[00817771020003]

Moist Heat or Steam Sterilization

[00817771020003]

Moist Heat or Steam Sterilization

[00817771020003]

Moist Heat or Steam Sterilization

[00817771020003]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2016-09-16

Devices Manufactured by Celling Biosciences

• 00817771028962 - Thermi Disposable RF Electrode (Qty1): 2023-09-25 Thermi Disposable RF Electrode - 50W Qty 1
• 00817771028979 - Thermi Disposable RF Electrode (Qty 5): 2023-09-25 Thermi Disposable RF Electrode - 50W Qty 5
• 00817771028986 - Thermi Disposable RF Electrode (Qty 1): 2023-09-25 Thermi Disposable RF Electrode - Qty 1
• 00817771028993 - Thermi Disposable RF Electrode (Qty 5): 2023-09-25 Thermi Disposable RF Electrode - Qty 5
• 00817771029006 - Reusable connector cable for disposable electrodes: 2023-09-25 Reusable connector cable for disposable electrodes
• 00817771029013 - RF Disposable Grounding Pad: 2023-09-25 RF Disposable Grounding Pad Qty 20
• 00817771029020 - Thermi Disposable RF Electrode (Qty 1): 2023-09-25 Thermi Disposable RF Electrode - Qty 1
• 00817771029037 - Thermi Disposable RF Electrode (Qty 5): 2023-09-25 Thermi Disposable RF Electrode - Qty 5