C-PLUS™* PEEK IBF CERVICAL SYSTEM 30-CW-1012-7

GUDID 00846468031893

INTERBODY FUSION DEVICE 10x12x7

Pioneer Surgical Technology, Inc.

Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis

• Primary Device ID: 00846468031893
• NIH Device Record Key: 389ab29b-ca28-45a4-baf8-902767603e97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C-PLUS™* PEEK IBF CERVICAL SYSTEM
• Version Model Number: 30-CW-1012-7
• Catalog Number: 30-CW-1012-7
• Company DUNS: 793384496
• Company Name: Pioneer Surgical Technology, Inc.
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846468031893 [Primary]
GS1	00846468033842 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133623

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar
• MQP: Spinal vertebral body replacement device

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-12-16

On-Brand Devices [C-PLUS™* PEEK IBF CERVICAL SYSTEM]

• 00846468031916: INTERBODY FUSION DEVICE 10x12x9
• 00846468031909: INTERBODY FUSION DEVICE 10x12x8
• 00846468031893: INTERBODY FUSION DEVICE 10x12x7
• 00846468031886: INTERBODY FUSION DEVICE 10x12x6
• 00846468031879: INTERBODY FUSION DEVICE 10x12x5
• 00846468031862: INTERBODY FUSION DEVICE 10x12x11
• 00846468031855: INTERBODY FUSION DEVICE 10x12x10