DISTRACT-THEN-ROTATE™* PEEK VBR/IBF SYSTEM 33-15-25

GUDID 00846468035105

15x25 Implant, Rotate Option, VBR

Pioneer Surgical Technology, Inc.

Vertebral body prosthesis

• Primary Device ID: 00846468035105
• NIH Device Record Key: 7c842985-ff38-4be4-a7ec-5e3c173ab5af
• Commercial Distribution Discontinuation: 2018-04-09
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: DISTRACT-THEN-ROTATE™* PEEK VBR/IBF SYSTEM
• Version Model Number: 33-15-25
• Catalog Number: 33-15-25
• 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(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	00846468035105 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133623

FDA Product Code

• 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: 5
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-12-16

On-Brand Devices [DISTRACT-THEN-ROTATE™* PEEK VBR/IBF SYSTEM]

• 00846468035167: 17x25 Implant, Rotate Option, VBR
• 00846468035136: 17x20 Implant, Rotate Option, VBR
• 00846468035105: 15x25 Implant, Rotate Option, VBR
• 00846468035075: 15x20 Implant, Rotate Option, VBR
• 00846468035068: 14x25 Implant, Rotate Option, VBR
• 00846468035051: 14x20 Implant, Rotate Option, VBR
• 00846468035020: 13x25 Implant, Rotate Option, VBR
• 00846468034993: 13x20 Implant, Rotate Option, VBR
• 00846468034986: 12x25 Implant, Rotate Option, VBR
• 00846468034979: 12x20 Implant, Rotate Option, VBR
• 00846468034948: 11x25 Implant, Rotate Option, VBR
• 00846468034917: 11x20 Implant, Rotate Option, VBR