INCITE INNOVATION ANCHORED CERVICAL INERBODY DEVICE 22-9223

GUDID B0382292231

ANCHORED CERVICAL INTERBODY DEVICE, 8MM IMPLANT, 12x14MM, 5 DEGREE

INCITE INNOVATION

Polymeric spinal interbody fusion cage

• Primary Device ID: B0382292231
• NIH Device Record Key: 33f3c1be-9703-4615-a437-a6690657a372
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INCITE INNOVATION ANCHORED CERVICAL INERBODY DEVICE
• Version Model Number: 22-9223
• Catalog Number: 22-9223
• Company DUNS: 005840144
• Company Name: INCITE INNOVATION
• 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: true
• Donation Id Number: false
• 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
HIBCC	B0382292231 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122008

FDA Product Code

• OVE: Intervertebral Fusion Device With Integrated Fixation, Cervical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-08
• Device Publish Date: 2020-03-31

Devices Manufactured by INCITE INNOVATION

• B0382272201 - INCITE INNOVATION ANCHORED CERVICAL INTERBODY DEVICE: 2020-04-08 ANCHORED CERVICAL INTERBODY DEVICE, 5MM IMPLANT, 14x16MM, 5 DEGREE
• B0382272211 - INCITE INNOVATION ANCHORED CERVICAL INTERBODY DEVICE: 2020-04-08 ANCHORED CERVICAL INTERBODY DEVICE, 6MM IMPLANT, 14x16MM, 5 DEGREE
• B0382272221 - INCITE INNOVATION ANCHORED CERVICAL INTERBODY DEVICE: 2020-04-08 ANCHORED CERVICAL INTERBODY DEVICE, 7MM IMPLANT, 14x16MM, 5 DEGREE
• B0382272231 - INCITE INNOVATION ANCHORED CERVICAL INTERBODY DEVICE: 2020-04-08 ANCHORED CERVICAL INTERBODY DEVICE, 8MM IMPLANT, 14x16MM, 5 DEGREE
• B0382272241 - INCITE INNOVATION ANCHORED CERVICAL INTERBODY DEVICE: 2020-04-08 ANCHORED CERVICAL INTERBODY DEVICE, 9MM IMPLANT, 14x16MM, 5 DEGREE
• B0382272251 - INCITE INNOVATION ANCHORED CERVICAL INTERBODY DEVICE: 2020-04-08 ANCHORED CERVICAL INTERBODY DEVICE, 10MM IMPLANT, 14x16MM, 5 DEGREE
• B0382292201 - INCITE INNOVATION ANCHORED CERVICAL INTERBODY DEVICE: 2020-04-08 ANCHORED CERVICAL INTERBODY, 5MM IMPLANT, 12x14MM, 5 DEGREE
• B0382292211 - INCITE INNOVATION ANCHORED CERVICAL INTERBODY DEVICE: 2020-04-08 ANCHORED CERVICAL INTERBODY DEVICE, 6MM IMPLANT, 12x14MM, 5 DEGREE