Streamline MIS Spinal Fixation System 05-PA-65-75

GUDID 00846468052430

CANNULATED SCREW, POLYAXIAL

Pioneer Surgical Technology, Inc.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00846468052430
• NIH Device Record Key: 20de2a00-c6d5-4d82-813e-df5a6dfd2f71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Streamline MIS Spinal Fixation System
• Version Model Number: 05-PA-65-75
• Catalog Number: 05-PA-65-75
• 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: false
• 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(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
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• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
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• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
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• Email: labeling@rtix.com
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• 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
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• Email: labeling@rtix.com
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• Email: labeling@rtix.com
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• 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
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• Phone: +1(906)226-9909
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• Phone: +1(906)226-9909
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• Phone: +1(906)226-9909
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• Phone: +1(906)226-9909
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• Phone: +1(906)226-9909
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• Phone: +1(906)226-9909
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• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
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• Phone: +1(906)226-9909
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• 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(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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00191083019659 [Primary]
GS1	00846468052430 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130286
• Premarket Notification: K192396

FDA Product Code

• MNI: Orthosis, spinal pedicle fixation
• NKB: Thoracolumbosacral pedicle screw system

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00846468052430]

Moist Heat or Steam Sterilization

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[00846468052430]

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[00846468052430]

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[00846468052430]

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[00846468052430]

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[00846468052430]

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[00846468052430]

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[00846468052430]

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[00846468052430]

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[00846468052430]

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[00846468052430]

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[00846468052430]

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[00846468052430]

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Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-05
• Device Publish Date: 2020-09-25

On-Brand Devices [Streamline MIS Spinal Fixation System]

• 00846468014865: Rod, Straight
• 00846468014858: Rod, Straight
• 00846468088453: FINAL DRIVER
• 00846468088446: THREADED SCREW INSERTER
• 00846468088439: SCREW INSERTER, THREADED
• 00846468088422: SCREW INSERTER
• 00846468086725: MIS, 50cm GUIDEWIRE, QTY 1
• 00846468086718: MIS HARD BONE TOOL
• 00846468086701: MIS CURVED PEDICLE FINDER
• 00846468086695: MIS COLLAPSABLE DILATOR
• 00846468063054: TARGETING NEEDLE DEPTH GAGE
• 00846468063047: TARGETING NEEDLE DEPTH GAGE
• 00846468052874: CANNULATED SCREW, POLYAXIAL
• 00846468052867: CANNULATED SCREW, POLYAXIAL
• 00846468052850: CANNULATED SCREW, POLYAXIAL
• 00846468052843: CANNULATED SCREW, POLYAXIAL
• 00846468052485: CANNULATED SCREW, POLYAXIAL
• 00846468052478: CANNULATED SCREW, POLYAXIAL
• 00846468052461: CANNULATED SCREW, POLYAXIAL
• 00846468052454: CANNULATED SCREW, POLYAXIAL
• 00846468052447: CANNULATED SCREW, POLYAXIAL
• 00846468052430: CANNULATED SCREW, POLYAXIAL
• 00846468052423: CANNULATED SCREW, POLYAXIAL
• 00846468052416: CANNULATED SCREW, POLYAXIAL
• 00846468052331: CANNULATED SCREW, POLYAXIAL
• 00846468015619: CANNULATED PEDICLE SCREW, POLYAXIAL
• 00846468015602: CANNULATED PEDICLE SCREW, POLYAXIAL
• 00846468015596: CANNULATED PEDICLE SCREW, POLYAXIAL
• 00846468015589: CANNULATED PEDICLE SCREW, POLYAXIAL
• 00846468015572: CANNULATED PEDICLE SCREW, POLYAXIAL
• 00846468015565: CANNULATED PEDICLE SCREW, POLYAXIAL
• 00846468015558: CANNULATED PEDICLE SCREW, POLYAXIAL
• 00846468015541: CANNULATED PEDICLE SCREW, POLYAXIAL
• 00846468015534: CANNULATED PEDICLE SCREW, POLYAXIAL
• 00846468015527: CANNULATED PEDICLE SCREW, POLYAXIAL
• 00846468015510: CANNULATED PEDICLE SCREW, POLYAXIAL
• 00846468015503: CANNULATED PEDICLE SCREW, POLYAXIAL
• 00846468015497: CANNULATED PEDICLE SCREW, POLYAXIAL
• 00846468015480: CANNULATED PEDICLE SCREW, POLYAXIAL
• 00846468015473: CANNULATED PEDICLE SCREW, POLYAXIAL
• 00846468015466: CANNULATED PEDICLE SCREW, POLYAXIAL
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