Streamline OCT

GUDID 00840311238521

High Angle Screw, Ø4.0mm x 24mm

Surgalign Spine Technologies, Inc.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00840311238521
• NIH Device Record Key: d5b6bf59-ffa6-4755-9d8c-40eacc8fe551
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Streamline OCT
• Version Model Number: 26-HA-40-24
• Company DUNS: 014520584
• Company Name: Surgalign Spine Technologies, 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(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840311238521 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172139

FDA Product Code

• NKG: Posterior cervical screw system

Sterilization

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

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

[00840311238521]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-13
• Device Publish Date: 2023-10-05

On-Brand Devices [Streamline OCT]

• 00840311242733: CERVICAL MODULAR HANDLE
• 00840311240920: STREAMLINE OCT, RIGID SCREW INSERTER
• 00840311240791: Yoke Manipulator, Slim
• 00840311240784: YOKE MANIPULATOR
• 00840311240777: YOKE MANIPULATOR
• 00840311240760: Variable Drill Guide
• 00840311240753: Variable Drill Guide
• 00840311240746: Variable Drill, Ø2.0mm
• 00840311240739: OCT Torque Limiting Handle
• 00840311240586: Pedicle Finder, Straight
• 00840311240579: Set Screw
• 00840311240562: Passive Locking Inserter
• 00840311240555: SCREW INSERTER
• 00840311240548: SCREW INSERTER
• 00840311240531: ROD TEMPLATE
• 00840311240524: Rod Template, 240mm
• 00840311240517: Rod Template, 120mm
• 00840311240500: ROD TEMPLATE
• 00840311240494: Rod Cutter, Dual
• 00840311240487: ROD CUTTER
• 00840311240470: ROD CUTTER
• 00840311240463: Rod Rocker
• 00840311240456: ROCKER REDUCER
• 00840311240449: Rod Reducer
• 00840311240432: ROD REDUCER
• 00840311240425: Rod Reducer
• 00840311240418: AO Ratchet Handle
• 00840311240401: ROD-TO-ROD CROSSLINK, EXTRA-EXTRA-LARGE
• 00840311240395: ROD-TO-ROD CROSSLINK, EXTRA-LARGE
• 00840311240388: Rod-to-Rod Crosslink - S, 26-34mm
• 00840311240371: Rod-to-Rod Crosslink - M, 32-40mm
• 00840311240364: Rod-to-Rod Crosslink - L, 38-46mm
• 00840311240357: Final Driver, Rod-to-Rod Crosslink
• 00840311240340: Palm Handle, OCP
• 00840311240326: Polyaxial Screw, Smooth Shank, 4.0 X 48mm
• 00840311240319: Polyaxial Screw, Smooth Shank, 4.0 X 46mm
• 00840311240302: Polyaxial Screw, Smooth Shank, 4.0 X 44mm
• 00840311240296: Polyaxial Screw, Smooth Shank, 4.0 X 42mm
• 00840311240289: Polyaxial Screw, Smooth Shank, 4.0 X 40mm
• 00840311240272: Polyaxial Screw, Smooth Shank, 4.0 X 38mm
• 00840311240265: Polyaxial Screw, Smooth Shank, 4.0 X 36mm
• 00840311240258: Polyaxial Screw, Smooth Shank, 4.0 X 34mm
• 00840311240241: Polyaxial Screw, Smooth Shank, 4.0 X 32mm
• 00840311240234: Polyaxial Screw, Smooth Shank, 4.0 X 30mm
• 00840311240227: Polyaxial Screw, Smooth Shank, 4.0 X 28mm
• 00840311240210: Polyaxial Screw, Smooth Shank, 4.0 X 26mm
• 00840311240203: Polyaxial Screw, Smooth Shank, 4.0 X 24mm
• 00840311240197: Polyaxial Screw, Smooth Shank, 4.0 X 22mm
• 00840311240180: Polyaxial Screw, Smooth Shank, 4.0 X 20mm
• 00840311240173: Polyaxial Screw, Smooth Shank, 3.5 X 48mm