STREAMLINE®* TL SPINAL FIXATION SYSTEM 01-PA-575-35

GUDID 00846468016210

PEDICLE SCREW, POLYAXIAL

Pioneer Surgical Technology, Inc.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00846468016210
• NIH Device Record Key: 7d26dead-9dd7-4c20-a7a5-84c2fba7cfb2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STREAMLINE®* TL SPINAL FIXATION SYSTEM
• Version Model Number: 01-PA-575-35
• Catalog Number: 01-PA-575-35
• 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(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(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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00191083008974 [Primary]
GS1	00846468016210 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140696
• Premarket Notification: K192800

FDA Product Code

• MNH: Orthosis, spondylolisthesis spinal fixation
• NKB: Thoracolumbosacral pedicle screw system

Sterilization

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

[00846468016210]

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[00846468016210]

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[00846468016210]

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[00846468016210]

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[00846468016210]

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[00846468016210]

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[00846468016210]

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[00846468016210]

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[00846468016210]

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[00846468016210]

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[00846468016210]

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[00846468016210]

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[00846468016210]

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[00846468016210]

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[00846468016210]

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[00846468016210]

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[00846468016210]

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[00846468016210]

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[00846468016210]

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[00846468016210]

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[00846468016210]

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[00846468016210]

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[00846468016210]

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[00846468016210]

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[00846468016210]

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[00846468016210]

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[00846468016210]

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[00846468016210]

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[00846468016210]

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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®* TL SPINAL FIXATION SYSTEM]

• 00846468016944: PEDICLE SCREW, POLYAXIAL
• 00846468016937: PEDICLE SCREW, POLYAXIAL
• 00846468016920: PEDICLE SCREW, POLYAXIAL
• 00846468016913: PEDICLE SCREW, POLYAXIAL
• 00846468016906: PEDICLE SCREW, POLYAXIAL
• 00846468016890: PEDICLE SCREW, POLYAXIAL
• 00846468016883: PEDICLE SCREW, POLYAXIAL
• 00846468016876: PEDICLE SCREW, POLYAXIAL
• 00846468016869: PEDICLE SCREW, POLYAXIAL
• 00846468016845: PEDICLE SCREW, POLYAXIAL
• 00846468016821: PEDICLE SCREW, POLYAXIAL
• 00846468016807: PEDICLE SCREW, POLYAXIAL
• 00846468016784: PEDICLE SCREW, POLYAXIAL
• 00846468016777: PEDICLE SCREW, POLYAXIAL
• 00846468016760: PEDICLE SCREW, POLYAXIAL
• 00846468016753: PEDICLE SCREW, POLYAXIAL
• 00846468016746: PEDICLE SCREW, POLYAXIAL
• 00846468016739: PEDICLE SCREW, POLYAXIAL
• 00846468016722: PEDICLE SCREW, POLYAXIAL
• 00846468016715: PEDICLE SCREW, POLYAXIAL
• 00846468016678: PEDICLE SCREW, POLYAXIAL
• 00846468016630: PEDICLE SCREW, POLYAXIAL
• 00846468016623: PEDICLE SCREW, POLYAXIAL
• 00846468016616: PEDICLE SCREW, POLYAXIAL
• 00846468016609: PEDICLE SCREW, POLYAXIAL
• 00846468016593: PEDICLE SCREW, POLYAXIAL
• 00846468016586: PEDICLE SCREW, POLYAXIAL
• 00846468016579: PEDICLE SCREW, POLYAXIAL
• 00846468016562: PEDICLE SCREW, POLYAXIAL
• 00846468016418: PEDICLE SCREW, POLYAXIAL
• 00846468016401: PEDICLE SCREW, POLYAXIAL
• 00846468016395: PEDICLE SCREW, POLYAXIAL
• 00846468016388: PEDICLE SCREW, POLYAXIAL
• 00846468016371: PEDICLE SCREW, POLYAXIAL
• 00846468016364: PEDICLE SCREW, POLYAXIAL
• 00846468016357: PEDICLE SCREW, POLYAXIAL
• 00846468016258: PEDICLE SCREW, POLYAXIAL
• 00846468016241: PEDICLE SCREW, POLYAXIAL
• 00846468016234: PEDICLE SCREW, POLYAXIAL
• 00846468016227: PEDICLE SCREW, POLYAXIAL
• 00846468016210: PEDICLE SCREW, POLYAXIAL
• 00846468016203: PEDICLE SCREW, POLYAXIAL
• 00846468016128: PEDICLE SCREW, POLYAXIAL
• 00846468016111: PEDICLE SCREW, POLYAXIAL
• 00846468016104: PEDICLE SCREW, POLYAXIAL
• 00846468016098: PEDICLE SCREW, POLYAXIAL
• 00846468016081: PEDICLE SCREW, POLYAXIAL
• 00846468016074: PEDICLE SCREW, POLYAXIAL