Streamline® TL Spinal Fixation System 01-PA-C-65-45

GUDID 00846468078430

Pedicle Screw, Polyaxial, Cannulated, 6.5mm (D) 45mm (L)

Pioneer Surgical Technology, Inc.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00846468078430
• NIH Device Record Key: c1ccbdda-6478-43b2-a6e9-cbe57262cb07
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Streamline® TL Spinal Fixation System
• Version Model Number: 01-PA-C-65-45
• Catalog Number: 01-PA-C-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(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• 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	00191083022673 [Primary]
GS1	00846468078430 [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

[00846468078430]

Moist Heat or Steam Sterilization

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[00846468078430]

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[00846468078430]

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[00846468078430]

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[00846468078430]

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[00846468078430]

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[00846468078430]

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[00846468078430]

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[00846468078430]

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[00846468078430]

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[00846468078430]

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[00846468078430]

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[00846468078430]

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[00846468078430]

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[00846468078430]

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[00846468078430]

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[00846468078430]

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[00846468078430]

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[00846468078430]

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[00846468078430]

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[00846468078430]

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[00846468078430]

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[00846468078430]

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[00846468078430]

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[00846468078430]

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[00846468078430]

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[00846468078430]

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[00846468078430]

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[00846468078430]

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[00846468078430]

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[00846468078430]

Moist Heat or Steam Sterilization

[00846468078430]

Moist Heat or Steam Sterilization

[00846468078430]

Moist Heat or Steam Sterilization

[00846468078430]

Moist Heat or Steam Sterilization

[00846468078430]

Moist Heat or Steam Sterilization

[00846468078430]

Moist Heat or Steam Sterilization

[00846468078430]

Moist Heat or Steam Sterilization

[00846468078430]

Moist Heat or Steam Sterilization

[00846468078430]

Moist Heat or Steam Sterilization

[00846468078430]

Moist Heat or Steam Sterilization

[00846468078430]

Moist Heat or Steam Sterilization

[00846468078430]

Moist Heat or Steam Sterilization

[00846468078430]

Moist Heat or Steam Sterilization

[00846468078430]

Moist Heat or Steam Sterilization

[00846468078430]

Moist Heat or Steam Sterilization

[00846468078430]

Moist Heat or Steam Sterilization

[00846468078430]

Moist Heat or Steam Sterilization

[00846468078430]

Moist Heat or Steam Sterilization

[00846468078430]

Moist Heat or Steam Sterilization

[00846468078430]

Moist Heat or Steam Sterilization

[00846468078430]

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[00846468078430]

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[00846468078430]

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[00846468078430]

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: 2016-08-23

On-Brand Devices [Streamline® TL Spinal Fixation System]

• 00846468080167: 8.5mm Case, Cannulated, Reduction
• 00846468080150: 4.5mm Case, Cannulated, Reduction
• 00846468080143: Implant Case, Cannulated, Reduction
• 00846468080136: Instrument Case, Cannulated, Reduction
• 00846468080129: 8.5mm Case, Cannulated, Polyaxial
• 00846468080112: 4.5mm Case, Cannulated, Polyaxial
• 00846468080105: Implant Case, Cannulated, Polyaxial
• 00846468080099: Instrument Case, Cannulated, Polyaxial
• 00846468080082: Screw Caddy, Cannulated, Polyaxial, Reduction
• 00846468080075: Screw Caddy, Cannulated, Polyaxial, Reduction
• 00846468080068: Screw Caddy, Cannulated, Polyaxial, Reduction
• 00846468080051: Screw Caddy, Cannulated, Polyaxial, Reduction
• 00846468080044: Screw Caddy, Cannulated, Polyaxial, Reduction
• 00846468080037: Screw Caddy, Cannulated, Polyaxial
• 00846468080020: Screw Caddy, Cannulated, Polyaxial
• 00846468080013: Screw Caddy, Cannulated, Polyaxial
• 00846468080006: Screw Caddy, Cannulated, Polyaxial
• 00846468079994: Screw Caddy, Cannulated, Polyaxial
• 00846468079680: Pedicle Screw, Polyaxial, Cannulated, Reduction 9.5mm (D) 100mm (L)
• 00846468079666: Pedicle Screw, Polyaxial, Cannulated, Reduction 9.5mm (D) 90mm (L)
• 00846468079642: Pedicle Screw, Polyaxial, Cannulated, Reduction 9.5mm (D) 80mm (L)
• 00846468079628: Pedicle Screw, Polyaxial, Cannulated, Reduction 9.5mm (D) 70mm (L)
• 00846468079604: Pedicle Screw, Polyaxial, Cannulated, Reduction 9.5mm (D) 60mm (L)
• 00846468079598: Pedicle Screw, Polyaxial, Cannulated, Reduction 9.5mm (D) 55mm (L)
• 00846468079581: Pedicle Screw, Polyaxial, Cannulated, Reduction 9.5mm (D) 50mm (L)
• 00846468079574: Pedicle Screw, Polyaxial, Cannulated, Reduction 9.5mm (D) 45mm (L)
• 00846468079567: Pedicle Screw, Polyaxial, Cannulated, Reduction 9.5mm (D) 40mm (L)
• 00846468079550: Pedicle Screw, Polyaxial, Cannulated, Reduction 8.5mm (D) 100mm (L)
• 00846468079543: Pedicle Screw, Polyaxial, Cannulated, Reduction 8.5mm (D) 95mm (L)
• 00846468079536: Pedicle Screw, Polyaxial, Cannulated, Reduction 8.5mm (D) 90mm (L)
• 00846468079529: Pedicle Screw, Polyaxial, Cannulated, Reduction 8.5mm (D) 85mm (L)
• 00846468079512: Pedicle Screw, Polyaxial, Cannulated, Reduction 8.5mm (D) 80mm (L)
• 00846468079505: Pedicle Screw, Polyaxial, Cannulated, Reduction 8.5mm (D) 75mm (L)
• 00846468079499: Pedicle Screw, Polyaxial, Cannulated, Reduction 8.5mm (D) 70mm (L)
• 00846468079482: Pedicle Screw, Polyaxial, Cannulated, Reduction 8.5mm (D) 65mm (L)
• 00846468079475: Pedicle Screw, Polyaxial, Cannulated, Reduction 8.5mm (D) 60mm (L)
• 00846468079468: Pedicle Screw, Polyaxial, Cannulated, Reduction 8.5mm (D) 55mm (L)
• 00846468079451: Pedicle Screw, Polyaxial, Cannulated, Reduction 8.5mm (D) 50mm (L)
• 00846468079444: Pedicle Screw, Polyaxial, Cannulated, Reduction 8.5mm (D) 45mm (L)
• 00846468079437: Pedicle Screw, Polyaxial, Cannulated, Reduction 8.5mm (D) 40mm (L)
• 00846468079420: Pedicle Screw, Polyaxial, Cannulated, Reduction 8.5mm (D) 35mm (L)
• 00846468079413: Pedicle Screw, Polyaxial, Cannulated, Reduction 8.5mm (D) 30mm (L)
• 00846468079406: Pedicle Screw, Polyaxial, Cannulated, Reduction 7.5mm (D) 100mm (L)
• 00846468079390: Pedicle Screw, Polyaxial, Cannulated, Reduction 7.5mm (D) 95mm (L)
• 00846468079383: Pedicle Screw, Polyaxial, Cannulated, Reduction 7.5mm (D) 90mm (L)
• 00846468079376: Pedicle Screw, Polyaxial, Cannulated, Reduction 7.5mm (D) 85mm (L)
• 00846468079369: Pedicle Screw, Polyaxial, Cannulated, Reduction 7.5mm (D) 80mm (L)
• 00846468079352: Pedicle Screw, Polyaxial, Cannulated, Reduction 7.5mm (D) 75mm (L)
• 00846468079345: Pedicle Screw, Polyaxial, Cannulated, Reduction 7.5mm (D) 70mm (L)
• 00846468079338: Pedicle Screw, Polyaxial, Cannulated, Reduction 7.5mm (D) 65mm (L)