DISTRACT-THEN-ROTATE™* PEEK VBR/IBF SYSTEM 33-17-20

GUDID 00846468035136

17x20 Implant, Rotate Option, VBR

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

• Primary Device ID: 00846468035136
• NIH Device Record Key: 73a660d5-0367-4249-b25e-d6b4012217e4
• 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: 33-17-20
• Catalog Number: 33-17-20
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846468035136 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133623

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

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