Streamline™* MIS Spinal Fixation System 04-55-PR-60

GUDID 00846468014636

ROD, PRE-BENT

Pioneer Surgical Technology, Inc.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00846468014636
• NIH Device Record Key: aa341f22-c831-4aba-bd2c-1b33e4d57b52
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Streamline™* MIS Spinal Fixation System
• Version Model Number: 04-55-PR-60
• Catalog Number: 04-55-PR-60
• 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
• 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
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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
• 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
• 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
• 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
• 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	00191083019079 [Primary]
GS1	00846468014636 [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

[00846468014636]

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[00846468014636]

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[00846468014636]

Moist Heat or Steam Sterilization

[00846468014636]

Moist Heat or Steam Sterilization

[00846468014636]

Moist Heat or Steam Sterilization

[00846468014636]

Moist Heat or Steam Sterilization

[00846468014636]

Moist Heat or Steam Sterilization

[00846468014636]

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[00846468014636]

Moist Heat or Steam Sterilization

[00846468014636]

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[00846468014636]

Moist Heat or Steam Sterilization

[00846468014636]

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[00846468014636]

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[00846468014636]

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Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-11-26

On-Brand Devices [Streamline™* MIS Spinal Fixation System]

• 00846468063146: THREADED SCREW INSERTER
• 00846468052836: CANNULATED SCREW, POLYAXIAL
• 00846468052829: CANNULATED SCREW, POLYAXIAL
• 00846468052812: CANNULATED SCREW, POLYAXIAL
• 00846468052805: CANNULATED SCREW, POLYAXIAL
• 00846468052799: CANNULATED SCREW, POLYAXIAL
• 00846468052690: CANNULATED SCREW, POLYAXIAL
• 00846468052683: CANNULATED SCREW, POLYAXIAL
• 00846468052676: CANNULATED SCREW, POLYAXIAL
• 00846468052669: CANNULATED SCREW, POLYAXIAL
• 00846468052652: CANNULATED SCREW, POLYAXIAL
• 00846468052645: CANNULATED SCREW, POLYAXIAL
• 00846468052553: CANNULATED SCREW, POLYAXIAL
• 00846468052546: CANNULATED SCREW, POLYAXIAL
• 00846468052539: CANNULATED SCREW, POLYAXIAL
• 00846468052522: CANNULATED SCREW, POLYAXIAL
• 00846468052515: CANNULATED SCREW, POLYAXIAL
• 00846468052508: CANNULATED SCREW, POLYAXIAL
• 00846468052492: CANNULATED SCREW, POLYAXIAL
• 00846468052409: CANNULATED SCREW, POLYAXIAL
• 00846468052393: CANNULATED SCREW, POLYAXIAL
• 00846468052386: CANNULATED SCREW, POLYAXIAL
• 00846468052379: CANNULATED SCREW, POLYAXIAL
• 00846468052362: CANNULATED SCREW, POLYAXIAL
• 00846468052355: CANNULATED SCREW, POLYAXIAL
• 00846468052348: CANNULATED SCREW, POLYAXIAL
• 00846468052324: CANNULATED SCREW, POLYAXIAL
• 00846468052317: CANNULATED SCREW, POLYAXIAL
• 00846468052300: CANNULATED SCREW, POLYAXIAL
• 00846468052294: CANNULATED SCREW, POLYAXIAL
• 00846468052287: CANNULATED SCREW, POLYAXIAL
• 00846468052270: CANNULATED SCREW, POLYAXIAL
• 00846468052263: CANNULATED SCREW, POLYAXIAL
• 00846468052256: CANNULATED SCREW, POLYAXIAL
• 00846468052249: CANNULATED SCREW, POLYAXIAL
• 00846468052232: CANNULATED SCREW, POLYAXIAL
• 00846468052225: CANNULATED SCREW, POLYAXIAL
• 00846468052218: CANNULATED SCREW, POLYAXIAL
• 00846468051983: ROD, STRAIGHT
• 00846468051976: ROD, STRAIGHT
• 00846468051969: ROD, STRAIGHT
• 00846468051952: ROD, STRAIGHT
• 00846468051945: ROD, STRAIGHT
• 00846468051938: ROD, STRAIGHT
• 00846468051921: ROD, STRAIGHT
• 00846468051914: ROD, STRAIGHT
• 00846468051907: ROD, STRAIGHT
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