Streamline MIS Spinal Fixation System 04-PA-65-45

GUDID 00846468015114

CANNULATED PEDICLE SCREW, POLYAXIAL

Pioneer Surgical Technology, Inc.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00846468015114
• NIH Device Record Key: 73f46d21-8636-4dbb-ade3-77b2b535ec0b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Streamline MIS Spinal Fixation System
• Version Model Number: 04-PA-65-45
• Catalog Number: 04-PA-65-45
• 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(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 Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00846468015114 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130286

FDA Product Code

• MNH: Orthosis, spondylolisthesis spinal fixation

Sterilization

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

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

[00846468015114]

Moist Heat or Steam Sterilization

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

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• 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
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• 00846468052485: CANNULATED SCREW, POLYAXIAL
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• 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
• 00846468015459: CANNULATED PEDICLE SCREW, POLYAXIAL
• 00846468015442: CANNULATED PEDICLE SCREW, POLYAXIAL
• 00846468015435: CANNULATED PEDICLE SCREW, POLYAXIAL
• 00846468015428: CANNULATED PEDICLE SCREW, POLYAXIAL
• 00846468015411: CANNULATED PEDICLE SCREW, POLYAXIAL
• 00846468015404: CANNULATED PEDICLE SCREW, POLYAXIAL
• 00846468015398: CANNULATED PEDICLE SCREW, POLYAXIAL
• 00846468015381: CANNULATED PEDICLE SCREW, POLYAXIAL
• 00846468015374: CANNULATED PEDICLE SCREW, POLYAXIAL