Streamline® OCT Occipito-Cervico-Thoracic System 26-PA-40-44

GUDID 00846468083656

Pedicle Screw, Polyaxial, 4.0mm (D) X 44mm (L)

Pioneer Surgical Technology, Inc.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00846468083656
• NIH Device Record Key: 85cee5a6-9a5d-403d-a21f-2b51348664eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Streamline® OCT Occipito-Cervico-Thoracic System
• Version Model Number: 26-PA-40-44
• Catalog Number: 26-PA-40-44
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846468083656 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161498

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[00846468083656]

Moist Heat or Steam Sterilization

[00846468083656]

Moist Heat or Steam Sterilization

[00846468083656]

Moist Heat or Steam Sterilization

[00846468083656]

Moist Heat or Steam Sterilization

[00846468083656]

Moist Heat or Steam Sterilization

[00846468083656]

Moist Heat or Steam Sterilization

[00846468083656]

Moist Heat or Steam Sterilization

[00846468083656]

Moist Heat or Steam Sterilization

[00846468083656]

Moist Heat or Steam Sterilization

[00846468083656]

Moist Heat or Steam Sterilization

[00846468083656]

Moist Heat or Steam Sterilization

[00846468083656]

Moist Heat or Steam Sterilization

[00846468083656]

Moist Heat or Steam Sterilization

[00846468083656]

Moist Heat or Steam Sterilization

[00846468083656]

Moist Heat or Steam Sterilization

[00846468083656]

Moist Heat or Steam Sterilization

[00846468083656]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-08
• Device Publish Date: 2019-03-31

On-Brand Devices [Streamline® OCT Occipito-Cervico-Thoracic System]

• 00846468084974: Head to Head Crosslink Bender
• 00846468084394: Drill, Stubby
• 00846468084387: Drill, Flex
• 00846468084370: Drill, Standard
• 00846468084363: Torque Limiting Handle, 23 in-lbs
• 00846468084356: DISTRACTOR, PARALLEL
• 00846468084349: COMPRESSOR, PARALLEL
• 00846468083847: YOKE MANIPULATOR
• 00846468083830: Counter Torque Tube, Connector
• 00846468083823: Counter Torque Tube, Inline
• 00846468083786: LOCKING SCREW INSERTER
• 00846468083779: ROD REDUCER
• 00846468083762: Rocker Reducer
• 00846468083755: Occipital-Cervical Assembly
• 00846468083748: Occipital-Cervical Assembly
• 00846468083731: Occipital-Cervical Assembly
• 00846468083724: Occipital-Cervical Assembly
• 00846468083717: ROD-TO-ROD CONNECTOR, 3.2mm-5.5mm CLOSED, 2X1
• 00846468083700: ROD-TO-ROD CONNECTOR, 3.2mm-5.5mm, INLINE, 1X1
• 00846468083694: ROD-TO-ROD CONNECTOR, 3.2mm-5.5mm, OPEN, 1X1
• 00846468083687: ROD-TO-ROD CONNECTOR, 3.2mm-5.5mm, CLOSED, 1X1
• 00846468083670: ROD-TO-ROD CONNECTOR, 3.2mm-3.2mm, CLOSED, 1X1
• 00846468083625: Pedicle Screw, Polyaxial, 4.0mm x 34mm
• 00846468083618: Pedicle Screw, Polyaxial, 4.0mm x 32mm
• 00846468083564: Pedicle Screw, Polyaxial, 3.5mm x 34mm
• 00846468083557: Pedicle Screw, Polyaxial, 3.5mm x 32mm
• 00846468080914: ROD TEMPLATE
• 00846468080907: ROD TEMPLATE
• 00846468079949: PEDICLE SCREW, POLYAXIAL
• 00846468079932: PEDICLE SCREW, POLYAXIAL
• 00846468079925: PEDICLE SCREW, POLYAXIAL
• 00846468079918: PEDICLE SCREW, POLYAXIAL
• 00846468079901: PEDICLE SCREW, POLYAXIAL
• 00846468079895: PEDICLE SCREW, POLYAXIAL
• 00846468079888: PEDICLE SCREW, POLYAXIAL
• 00846468079871: PEDICLE SCREW, POLYAXIAL
• 00846468079864: PEDICLE SCREW, POLYAXIAL
• 00846468079857: PEDICLE SCREW, POLYAXIAL
• 00846468079840: PEDICLE SCREW, POLYAXIAL
• 00846468079833: PEDICLE SCREW, POLYAXIAL
• 00846468079826: PEDICLE SCREW, POLYAXIAL
• 00846468079819: PEDICLE SCREW, POLYAXIAL
• 00846468079802: PEDICLE SCREW, POLYAXIAL
• 00846468079796: PEDICLE SCREW, POLYAXIAL
• 00846468079727: 3.2mm To 5.5mm Transition Rod
• 00846468079710: 3.2mm To 5.5mm Transition Rod
• 00846468079697: FINAL LOCKER
• 00846468078065: FINAL DRIVER
• 00846468078041: Pre-Bent Co-Cr Rod, 110mm length
• 00846468078034: Pre-Bent Co-Cr Rod, 90mm length