C-PLUS™* PEEK VBR/IBF SYSTEM

GUDID 00846468031565

C-PLUS Ta 12 x 14 x 7

Pioneer Surgical Technology, Inc.

Vertebral body prosthesis

• Primary Device ID: 00846468031565
• NIH Device Record Key: a2092619-03ae-481e-b229-3c1960996fe7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C-PLUS™* PEEK VBR/IBF SYSTEM
• Version Model Number: 30-CTA-1214-7
• 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
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846468031565 [Primary]
GS1	00846468033729 [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 VBR/IBF SYSTEM]

• 00846468031985: 12X14x9MM CPLUS NO WEB
• 00846468031978: 12X14x8MM CPLUS NO WEB
• 00846468031961: 12X14x7MM CPLUS NO WEB
• 00846468031954: 12X14x6MM CPLUS NO WEB
• 00846468031947: 12X14x5MM CPLUS NO WEB
• 00846468031930: 12X14x11MM CPLUS NO WEB
• 00846468031923: 12X14x10MM CPLUS NO WEB
• 00846468031589: C-PLUS Ta 12 x 14 x 9
• 00846468031572: C-PLUS Ta 12 x 14 x 8
• 00846468031565: C-PLUS Ta 12 x 14 x 7
• 00846468031558: C-PLUS Ta 12 x 14 x 6
• 00846468031466: 14.5 X 17 X 9MM C-PLUS, VBR
• 00846468031442: 14.5 X 17 X 8MM C-PLUS, VBR
• 00846468031428: 14.5 X 17 X 7MM C-PLUS, VBR
• 00846468031404: 14.5 X 17 X 6MM C-PLUS, VBR
• 00846468031381: 14.5 X 17 X 5MM C-PLUS, VBR
• 00846468031367: 14.5 X 17 X 11MM C-PLUS, VBR
• 00846468031343: 14.5 X 17 X 10MM C-PLUS, VBR
• 00846468031329: PEEK +, C-PLUS, VBR. 12 x 14 x 9
• 00846468031305: PEEK +, C-PLUS, VBR. 12 x 14 x 8
• 00846468031282: PEEK +, C-PLUS, VBR. 12 x 14 x 7
• 00846468031268: PEEK +, C-PLUS, VBR. 12 x 14 x 6
• 00846468031244: PEEK +, C-PLUS, VBR. 12 x 14 x 5
• 00846468031220: PEEK +, C-PLUS, VBR.. 12 x 14 x 11
• 00846468031206: PEEK +, C-PLUS, VBR.. 12 x 14 x 10
• 00846468031183: PEEK +, C-PLUS, VBR 10 x 12 x 9
• 00846468031169: PEEK +, C-PLUS, VBR 10 x 12 x 8
• 00846468031145: PEEK +, C-PLUS, VBR 10 x 12 x 7
• 00846468031121: PEEK +, C-PLUS, VBR 10 x 12 x 6
• 00846468031107: PEEK +, C-PLUS, VBR 10 x 12 x 5
• 00846468031084: PEEK +, C-PLUS, VBR. 10 x 12 x 11
• 00846468031060: PEEK +, C-PLUS, VBR. 10 x 12 x 10