Streamline TL Spinal Fixation System 01-PA-775-50

GUDID 00191083009148

Pedicle Screw, Polyaxial

Pioneer Surgical Technology, Inc.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00191083009148
• NIH Device Record Key: 89ce0515-667d-4cdd-9a84-1238af013c06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Streamline TL Spinal Fixation System
• Version Model Number: 01-PA-775-50
• Catalog Number: 01-PA-775-50
• Company DUNS: 793384496
• Company Name: Pioneer Surgical Technology, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)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	00191083009148 [Primary]
GS1	00846468016616 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192800

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

[00191083009148]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-05
• Device Publish Date: 2021-06-25

On-Brand Devices [Streamline TL Spinal Fixation System]

• 00846468080839: Instrument Case, Empty
• 00846468080822: Instrument Case, Empty
• 00846468080815: Instrument Case, Empty
• 00846468080808: Instrument Case, Empty
• 00846468080792: Caddy, Crosslink, Variable, Empty
• 00846468080785: Case, Crosslink, Empty
• 00846468080778: Long Rod Caddy, Empty
• 00846468080761: Long Rod Caddy, Empty
• 00846468080754: Caddy, Crosslink, Fixed, Empty
• 00846468080747: Lateral Offset Caddy, Empty
• 00846468080730: Caddy, Rod Connector, Empty
• 00846468080723: Implant Case, Empty
• 00846468080716: Medium Rod Caddy, Empty
• 00846468080709: Small Rod Caddy, Empty
• 00846468080693: Large Rod Caddy, Empty
• 00846468080686: 9.5mm Screw Caddy, Long, Polyaxial, Empty
• 00846468080679: 9.5mm Screw Caddy, Polyaxial, Empty
• 00846468080662: 8.5mm Screw Caddy, Long, Polyaxial, Empty
• 00846468080655: 8.5mm Screw Caddy, Polyaxial, Empty
• 00846468080648: 7.5mm Screw Caddy, Long, Polyaxial, Empty
• 00846468080631: 6.5mm Screw Caddy, Long, Polyaxial, Empty
• 00846468080624: 4.5mm Screw Caddy, Polyaxial, Empty
• 00846468080617: Screw Caddy, Cannulated, Polyaxial, Reduction
• 00846468080600: Screw Caddy, Cannulated, Polyaxial, Reduction
• 00846468080594: Screw Caddy, Cannulated, Polyaxial, Reduction
• 00846468080587: 7.5mm Screw Caddy, Fixed, Empty
• 00846468080570: 6.5mm Screw Caddy, Fixed, Empty
• 00846468080563: 5.5mm Screw Caddy, Fixed, Empty
• 00846468080556: 4.5mm Screw Caddy, Fixed, Empty
• 00846468080549: 7.5mm Screw Caddy, Polyaxial, Empty
• 00846468080532: 6.5mm Screw Caddy, Polyaxial, Empty
• 00846468080525: 5.5mm Screw Caddy, Polyaxial, Empty
• 00846468080518: Implant Case, Empty
• 00846468079734: CROSSLINK HOLDER
• 00846468006907: Set Screw Caddy, Empty
• 00846468006631: CROSSLINK COUNTER TORQUE TUBE
• 00846468006624: VARIABLE CROSSLINK BENDER MALE
• 00846468006617: VARIABLE CROSSLINK BENDER FEMALE
• 00846468006600: FIXED CROSSLINK BENDER RIGHT
• 00846468006594: FIXED CROSSLINK BENDER LEFT
• 00846468006549: CADDY, X-LINK, FIXED
• 00846468006402: CROSSLINK TORQUE HANDLE
• 00846468006396: CROSSLINK PROVISIONAL INSERTER
• 00846468006389: CROSSLINK GAUGE
• 00846468006372: CROSSLINK FINAL DRIVER
• 00846468001834: STREAMLINE TL, BANDED PEDICLE MARKER
• 00846468000530: STREAMLINE TL, REDUCTION SCREW DEROTATOR
• 00846468000103: STREAMLINE TL, DISTRACTOR, STRAIGHT TIP
• 00846468000097: STREAMLINE TL, COMPRESSOR, STRAIGHT TIP
• 00846468032951: STREAMLINE TL, ROD WRENCH,ORIENTATED HEX