Streamline OCT

GUDID 00840311238651

High Angle Screw, Ø4.0mm x 50mm

Surgalign Spine Technologies, Inc.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00840311238651
NIH Device Record Keya7bf7d52-5e10-4268-a547-565974427a4a
Commercial Distribution StatusIn Commercial Distribution
Brand NameStreamline OCT
Version Model Number26-HA-40-50
Company DUNS014520584
Company NameSurgalign Spine Technologies, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(844)894-7752
Emailcustomerservice@surgalign.com
Phone+1(844)894-7752
Emailcustomerservice@surgalign.com
Phone+1(844)894-7752
Emailcustomerservice@surgalign.com
Phone+1(844)894-7752
Emailcustomerservice@surgalign.com
Phone+1(844)894-7752
Emailcustomerservice@surgalign.com
Phone+1(844)894-7752
Emailcustomerservice@surgalign.com
Phone+1(844)894-7752
Emailcustomerservice@surgalign.com
Phone+1(844)894-7752
Emailcustomerservice@surgalign.com
Phone+1(844)894-7752
Emailcustomerservice@surgalign.com
Phone+1(844)894-7752
Emailcustomerservice@surgalign.com
Phone+1(844)894-7752
Emailcustomerservice@surgalign.com
Phone+1(844)894-7752
Emailcustomerservice@surgalign.com
Phone+1(844)894-7752
Emailcustomerservice@surgalign.com
Phone+1(844)894-7752
Emailcustomerservice@surgalign.com
Phone+1(844)894-7752
Emailcustomerservice@surgalign.com
Phone+1(844)894-7752
Emailcustomerservice@surgalign.com
Phone+1(844)894-7752
Emailcustomerservice@surgalign.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100840311238651 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKGPosterior cervical screw system

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840311238651]

Moist Heat or Steam Sterilization

[00840311238651]

Moist Heat or Steam Sterilization

[00840311238651]

Moist Heat or Steam Sterilization

[00840311238651]

Moist Heat or Steam Sterilization

[00840311238651]

Moist Heat or Steam Sterilization

[00840311238651]

Moist Heat or Steam Sterilization

[00840311238651]

Moist Heat or Steam Sterilization

[00840311238651]

Moist Heat or Steam Sterilization

[00840311238651]

Moist Heat or Steam Sterilization

[00840311238651]

Moist Heat or Steam Sterilization

[00840311238651]

Moist Heat or Steam Sterilization

[00840311238651]

Moist Heat or Steam Sterilization

[00840311238651]

Moist Heat or Steam Sterilization

[00840311238651]

Moist Heat or Steam Sterilization

[00840311238651]

Moist Heat or Steam Sterilization

[00840311238651]

Moist Heat or Steam Sterilization

[00840311238651]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-13
Device Publish Date2023-10-05

On-Brand Devices [Streamline OCT]

00840311242733CERVICAL MODULAR HANDLE
00840311240920STREAMLINE OCT, RIGID SCREW INSERTER
00840311240791Yoke Manipulator, Slim
00840311240784YOKE MANIPULATOR
00840311240777YOKE MANIPULATOR
00840311240760Variable Drill Guide
00840311240753Variable Drill Guide
00840311240746Variable Drill, Ø2.0mm
00840311240739OCT Torque Limiting Handle
00840311240586Pedicle Finder, Straight
00840311240579Set Screw
00840311240562Passive Locking Inserter
00840311240555SCREW INSERTER
00840311240548SCREW INSERTER
00840311240531ROD TEMPLATE
00840311240524Rod Template, 240mm
00840311240517Rod Template, 120mm
00840311240500ROD TEMPLATE
00840311240494Rod Cutter, Dual
00840311240487ROD CUTTER
00840311240470ROD CUTTER
00840311240463Rod Rocker
00840311240456ROCKER REDUCER
00840311240449Rod Reducer
00840311240432ROD REDUCER
00840311240425Rod Reducer
00840311240418AO Ratchet Handle
00840311240401ROD-TO-ROD CROSSLINK, EXTRA-EXTRA-LARGE
00840311240395ROD-TO-ROD CROSSLINK, EXTRA-LARGE
00840311240388Rod-to-Rod Crosslink - S, 26-34mm
00840311240371Rod-to-Rod Crosslink - M, 32-40mm
00840311240364Rod-to-Rod Crosslink - L, 38-46mm
00840311240357Final Driver, Rod-to-Rod Crosslink
00840311240340Palm Handle, OCP
00840311240326Polyaxial Screw, Smooth Shank, 4.0 X 48mm
00840311240319Polyaxial Screw, Smooth Shank, 4.0 X 46mm
00840311240302Polyaxial Screw, Smooth Shank, 4.0 X 44mm
00840311240296Polyaxial Screw, Smooth Shank, 4.0 X 42mm
00840311240289Polyaxial Screw, Smooth Shank, 4.0 X 40mm
00840311240272Polyaxial Screw, Smooth Shank, 4.0 X 38mm
00840311240265Polyaxial Screw, Smooth Shank, 4.0 X 36mm
00840311240258Polyaxial Screw, Smooth Shank, 4.0 X 34mm
00840311240241Polyaxial Screw, Smooth Shank, 4.0 X 32mm
00840311240234Polyaxial Screw, Smooth Shank, 4.0 X 30mm
00840311240227Polyaxial Screw, Smooth Shank, 4.0 X 28mm
00840311240210Polyaxial Screw, Smooth Shank, 4.0 X 26mm
00840311240203Polyaxial Screw, Smooth Shank, 4.0 X 24mm
00840311240197Polyaxial Screw, Smooth Shank, 4.0 X 22mm
00840311240180Polyaxial Screw, Smooth Shank, 4.0 X 20mm
00840311240173Polyaxial Screw, Smooth Shank, 3.5 X 48mm
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.