BULLET-TIP PEEK VBR/IBF SYSTEM 32-16-26

GUDID 00846468034269

VBR, Bullet-Tip Option, 16x26 Spacer

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: 00846468034269
• NIH Device Record Key: 89cf9c10-47fe-428c-b1b0-2e95b80e5348
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BULLET-TIP PEEK VBR/IBF SYSTEM
• Version Model Number: 32-16-26
• Catalog Number: 32-16-26
• 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	00846468034269 [Primary]
GS1	00846468090777 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133623

FDA Product Code

• MQP: Spinal vertebral body replacement device
• ODP: Intervertebral fusion device with bone graft, cervical

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 [BULLET-TIP PEEK VBR/IBF SYSTEM]

• 00846468074760: INSTRUMENT CASE
• 00846468066123: TRIAL SPACER
• 00846468054144: 17mm x 26mm Lordotic Bullet-Tip
• 00846468054137: 16mm x 26mm Lordotic Bullet-Tip
• 00846468054120: 15mm x 26mm Lordotic Bullet-Tip
• 00846468054113: 14mm x 26mm Lordotic Bullet-Tip
• 00846468054106: 13mm x 26mm Lordotic Bullet-Tip
• 00846468054090: 12mm x 26mm Lordotic Bullet-Tip
• 00846468054083: 11mm x 26mm Lordotic Bullet-Tip
• 00846468054076: 10mm x 26mm Lordotic Bullet-Tip
• 00846468054069: 9mm x 26mm Lordotic Bullet-Tip
• 00846468054052: 8mm x 26mm Lordotic Bullet-Tip
• 00846468054038: 16mm x 22mm Lordotic Bullet-Tip
• 00846468054021: 15mm x 22mm Lordotic Bullet-Tip
• 00846468054014: 14mm x 22mm Lordotic Bullet-Tip
• 00846468054007: 13mm x 22mm Lordotic Bullet-Tip
• 00846468053994: 12mm x 22mm Lordotic Bullet-Tip
• 00846468053987: 11mm x 22mm Lordotic Bullet-Tip
• 00846468053970: 10mm x 22mm Lordotic Bullet-Tip
• 00846468053963: 9mm x 22mm Lordotic Bullet-Tip
• 00846468053956: 8mm x 22mm Lordotic Bullet-Tip
• 00846468034467: VBR, Bullet-Tip Option, 9x32 Spacer
• 00846468034443: VBR, Bullet-Tip Option, 9x26 Spacer
• 00846468034429: VBR, Bullet-Tip Option, 9x22 Spacer
• 00846468034405: VBR, Bullet-Tip Option, 8x32 Spacer
• 00846468034382: VBR, Bullet-Tip Option, 8x26 Spacer
• 00846468034368: VBR, Bullet-Tip Option, 8x22 Spacer
• 00846468034344: VBR, Bullet-Tip Option, 17x32 Spacer
• 00846468034320: VBR, Bullet-Tip Option, 17x26 Spacer
• 00846468034283: VBR, Bullet-Tip Option, 16x32 Spacer
• 00846468034269: VBR, Bullet-Tip Option, 16x26 Spacer
• 00846468034245: VBR, Bullet-Tip Option, 16x22 Spacer
• 00846468034221: VBR, Bullet-Tip Option, 15x32 Spacer
• 00846468034207: Bullett-Tip Option, 15x26 Spacer
• 00846468034184: VBR, Bullet-Tip Option, 15x22 Spacer
• 00846468034160: VBR, Bullet-Tip Option, 14x32 Spacer
• 00846468034146: VBR, Bullet-Tip Option, 14x26 Spacer
• 00846468034122: VBR, Bullet-Tip Option, 14x22 Spacer
• 00846468034108: VBR, Bullet-Tip Option, 13x32 Spacer
• 00846468034085: VBR, Bullet-Tip Option, 13x26 Spacer
• 00846468034061: VBR, Bullet-Tip Option, 13x22 Spacer
• 00846468034047: VBR, Bullet-Tip Option, 12x32 Spacer
• 00846468034023: VBR, Bullet-Tip Option, 12x26 Spacer
• 00846468034009: VBR, Bullet-Tip Option, 12x22 Spacer
• 00846468033989: VBR, Bullet-Tip Option, 11x32 Spacer
• 00846468033965: VBR, Bullet-Tip Option, 11x26 Spacer
• 00846468033941: VBR, Bullet-Tip Option, 11x22 Spacer
• 00846468033927: VBR, Bullet-Tip Option, 10x32 Spacer
• 00846468033910: Lordotic Bullet-Tip Option, 10x26 Spacer
• 00846468033897: VBR, Bullet-Tip Option, 10x26 Spacer