STREAMLINE™* TL SPINAL FIXATION SYSTEM 01-FX-65-30

GUDID 00846468053154

PEDICLE SCREW, FIXED

Pioneer Surgical Technology, Inc.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00846468053154
• NIH Device Record Key: 713e002d-4b40-4b20-b7ff-e2f8a5def824
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STREAMLINE™* TL SPINAL FIXATION SYSTEM
• Version Model Number: 01-FX-65-30
• Catalog Number: 01-FX-65-30
• 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
• 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	00191083018379 [Primary]
GS1	00846468053154 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140696
• Premarket Notification: K192800

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• MNI: ORTHOSIS, SPINAL PEDICLE FIXATION

Sterilization

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

[00846468053154]

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[00846468053154]

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[00846468053154]

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[00846468053154]

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[00846468053154]

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[00846468053154]

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[00846468053154]

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[00846468053154]

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[00846468053154]

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[00846468053154]

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[00846468053154]

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[00846468053154]

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[00846468053154]

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[00846468053154]

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[00846468053154]

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[00846468053154]

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[00846468053154]

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[00846468053154]

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[00846468053154]

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[00846468053154]

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[00846468053154]

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[00846468053154]

Moist Heat or Steam Sterilization

[00846468053154]

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[00846468053154]

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[00846468053154]

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[00846468053154]

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[00846468053154]

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[00846468053154]

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[00846468053154]

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[00846468053154]

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[00846468053154]

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[00846468053154]

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[00846468053154]

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[00846468053154]

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[00846468053154]

Moist Heat or Steam Sterilization

[00846468053154]

Moist Heat or Steam Sterilization

[00846468053154]

Moist Heat or Steam Sterilization

[00846468053154]

Moist Heat or Steam Sterilization

[00846468053154]

Moist Heat or Steam Sterilization

[00846468053154]

Moist Heat or Steam Sterilization

[00846468053154]

Moist Heat or Steam Sterilization

[00846468053154]

Moist Heat or Steam Sterilization

[00846468053154]

Moist Heat or Steam Sterilization

[00846468053154]

Moist Heat or Steam Sterilization

[00846468053154]

Moist Heat or Steam Sterilization

[00846468053154]

Moist Heat or Steam Sterilization

[00846468053154]

Moist Heat or Steam Sterilization

[00846468053154]

Moist Heat or Steam Sterilization

[00846468053154]

Moist Heat or Steam Sterilization

[00846468053154]

Moist Heat or Steam Sterilization

[00846468053154]

Moist Heat or Steam Sterilization

[00846468053154]

Moist Heat or Steam Sterilization

[00846468053154]

Moist Heat or Steam Sterilization

[00846468053154]

Moist Heat or Steam Sterilization

[00846468053154]

Moist Heat or Steam Sterilization

[00846468053154]

Moist Heat or Steam Sterilization

[00846468053154]

Moist Heat or Steam Sterilization

[00846468053154]

Moist Heat or Steam Sterilization

[00846468053154]

Moist Heat or Steam Sterilization

[00846468053154]

Moist Heat or Steam Sterilization

[00846468053154]

Moist Heat or Steam Sterilization

[00846468053154]

Moist Heat or Steam Sterilization

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]

• 00846468062989: PEDICLE SCREW, POLYAXIAL
• 00846468062972: PEDICLE SCREW, POLYAXIAL
• 00846468062965: PEDICLE SCREW, POLYAXIAL
• 00846468062958: PEDICLE SCREW, POLYAXIAL
• 00846468062941: PEDICLE SCREW, POLYAXIAL
• 00846468062880: PEDICLE SCREW, POLYAXIAL
• 00846468062873: PEDICLE SCREW, POLYAXIAL
• 00846468062866: PEDICLE SCREW, POLYAXIAL
• 00846468062859: PEDICLE SCREW, POLYAXIAL
• 00846468062842: PEDICLE SCREW, POLYAXIAL
• 00846468062835: PEDICLE SCREW, POLYAXIAL
• 00846468062781: PEDICLE SCREW, POLYAXIAL
• 00846468062774: PEDICLE SCREW, POLYAXIAL
• 00846468062767: PEDICLE SCREW, POLYAXIAL
• 00846468062750: PEDICLE SCREW, POLYAXIAL
• 00846468057206: OPEN PARALLEL ROD CONNECTOR
• 00846468057190: CLOSED PARALLEL ROD CONNECTOR
• 00846468056865: REDUCTION SCREW
• 00846468056858: REDUCTION SCREW
• 00846468056841: REDUCTION SCREW
• 00846468056834: REDUCTION SCREW
• 00846468056827: REDUCTION SCREW
• 00846468056810: REDUCTION SCREW
• 00846468056803: REDUCTION SCREW
• 00846468056711: REDUCTION SCREW
• 00846468056704: REDUCTION SCREW
• 00846468056698: REDUCTION SCREW
• 00846468056681: REDUCTION SCREW
• 00846468056674: REDUCTION SCREW
• 00846468056667: REDUCTION SCREW
• 00846468056650: REDUCTION SCREW
• 00846468056643: REDUCTION SCREW
• 00846468056636: REDUCTION SCREW
• 00846468056629: REDUCTION SCREW
• 00846468056612: REDUCTION SCREW
• 00846468056605: REDUCTION SCREW
• 00846468056599: REDUCTION SCREW
• 00846468056582: REDUCTION SCREW
• 00846468053710: LATERAL OFFSET CONNECTOR
• 00846468053703: LATERAL OFFSET CONNECTOR
• 00846468053697: LATERAL OFFSET CONNECTOR
• 00846468053369: PEDICLE SCREW, FIXED
• 00846468053352: PEDICLE SCREW, FIXED
• 00846468053345: PEDICLE SCREW, FIXED
• 00846468053338: PEDICLE SCREW, FIXED
• 00846468053321: PEDICLE SCREW, FIXED
• 00846468053314: PEDICLE SCREW, FIXED
• 00846468053307: PEDICLE SCREW, FIXED
• 00846468053215: PEDICLE SCREW, FIXED
• 00846468053208: PEDICLE SCREW, FIXED