BULLET-TIP PEEK VBR/IBF SYSTEM 32-9-22

GUDID 00846468034429

VBR, Bullet-Tip Option, 9x22 Spacer

Pioneer Surgical Technology, Inc.

Vertebral body prosthesis

• Primary Device ID: 00846468034429
• NIH Device Record Key: c79606b8-ece6-4b66-9fdb-629db8f5adff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BULLET-TIP PEEK VBR/IBF SYSTEM
• Version Model Number: 32-9-22
• Catalog Number: 32-9-22
• 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(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(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	00846468034429 [Primary]
GS1	00846468090906 [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