Streamline® MIS Spinal Fixation System 05-PA-75-85

GUDID 00846468052607

CANNULATED SCREW, POLYAXIAL

Pioneer Surgical Technology, Inc.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00846468052607
• NIH Device Record Key: c6fd47a9-e67b-48d4-a6b0-cd6f5bc34be1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Streamline® MIS Spinal Fixation System
• Version Model Number: 05-PA-75-85
• Catalog Number: 05-PA-75-85
• 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
• 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	00191083019826 [Primary]
GS1	00846468052607 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130286
• Premarket Notification: K192396

FDA Product Code

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

Sterilization

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

[00846468052607]

Moist Heat or Steam Sterilization

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[00846468052607]

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[00846468052607]

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[00846468052607]

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Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-11-06
• Device Publish Date: 2018-10-06

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

• 00846468065966: Rod Caddy Lid Replacement
• 00846468065959: Rod Caddy Lid Replacement
• 00846468065942: Rod Caddy Lid Replacement
• 00846468065935: Rod Caddy Lid Replacement
• 00846468065881: SCREW CADDY
• 00846468064143: INSTRUMENT CASE 2, EMPTY
• 00846468064136: INSTRUMENT CASE 1, EMPTY
• 00846468063139: STRAIGHT LONG ROD CADDY
• 00846468063122: STRAIGHT LARGE ROD CADDY
• 00846468063115: STRAIGHT SMALL ROD CADDY
• 00846468063108: PRE-BENT LONG ROD CADDY
• 00846468061159: LARGE ROD CADDY LID REPLACEMENT
• 00846468061142: SMALL ROD CADDY LID REPLACEMENT
• 00846468061135: SCREW CADDY LID REPLACEMENT
• 00846468060343: SEQUENTIAL DILATOR 4
• 00846468060336: SEQUENTIAL DILATOR 3
• 00846468060329: SEQUENTIAL DILATOR 2
• 00846468060312: SEQUENTIAL DILATOR 1
• 00846468060305: CANNULATED TAP, BLUNT
• 00846468060299: CANNULATED TAP, BLUNT
• 00846468060282: CANNULATED TAP, BLUNT
• 00846468060275: CANNULATED TAP, BLUNT
• 00846468060268: CANNULATED TAP, BLUNT
• 00846468060251: CANNULATED TAP, BLUNT
• 00846468060244: CANNULATED TAP, BLUNT
• 00846468060237: CANNULATED TAP, BLUNT
• 00846468060220: CANNULATED TAP, BLUNT
• 00846468060213: CANNULATED TAP, BLUNT
• 00846468060206: 8.5mm AUXILIARY CASE, EMPTY
• 00846468060190: 4.5mm AUXILIARY CASE, EMPTY
• 00846468060183: GUIDEWIRE, SHARP TIP, SS
• 00846468060176: GUIDEWIRE, SHARP TIP, SS
• 00846468060169: GUIDEWIRE, SHARP TIP, SS
• 00846468060152: GUIDEWIRE, SHARP TIP, SS
• 00846468060145: GUIDEWIRE, SHARP TIP, SS
• 00846468060138: GUIDEWIRE, SHARP TIP, SS
• 00846468060121: GUIDEWIRE, DULL TIP, SS
• 00846468060114: GUIDEWIRE, DULL TIP, SS
• 00846468060107: GUIDEWIRE, DULL TIP, SS
• 00846468060091: GUIDEWIRE, DULL TIP, SS
• 00846468060084: GUIDEWIRE, DULL TIP, SS
• 00846468060077: GUIDEWIRE, DULL TIP, SS
• 00846468060060: GUIDEWIRE, BLUNT TIP, SS
• 00846468060053: GUIDEWIRE, BLUNT TIP, SS
• 00846468060046: GUIDEWIRE, BLUNT TIP, SS
• 00846468060039: GUIDEWIRE, BLUNT TIP, SS
• 00846468060022: GUIDEWIRE, BLUNT TIP, SS
• 00846468060015: GUIDEWIRE, BLUNT TIP, SS
• 00846468060008: IMPLANT CASE, EMPTY
• 00846468056513: GUIDEWIRE, BLUNT TIP, THREADED, SS