4CIS VERTU SPINE SYSTEM 1036-6535

GUDID 00840185305305

Poly-axial Reduction Pedicle Screw, Ø mm : 6.5, Length mm: 35 The Spinal Fixation System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, nuts, transverse (cross) link and associated instruments. Rigid fixation is provided by pedicle screws inserted into the vertebral body through pedicle of the lumbar spine via posterior approach. This system will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion through open surgery. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the mature patient. The implant components are supplied non-sterile single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F136. Also, Specialized instruments are available for the application and removal of the Spinal Fixation System

SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00840185305305
NIH Device Record Key93785875-e280-4298-aa20-f81a8e9c4539
Commercial Distribution StatusIn Commercial Distribution
Brand Name4CIS VERTU SPINE SYSTEM
Version Model NumberAISP-1036-6535
Catalog Number1036-6535
Company DUNS868354728
Company NameSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
Device Count1
DM Exempttrue
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840185305305 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840185305305]

Moist Heat or Steam Sterilization

[00840185305305]

Moist Heat or Steam Sterilization

[00840185305305]

Moist Heat or Steam Sterilization

[00840185305305]

Moist Heat or Steam Sterilization

[00840185305305]

Moist Heat or Steam Sterilization

[00840185305305]

Moist Heat or Steam Sterilization

[00840185305305]

Moist Heat or Steam Sterilization

[00840185305305]

Moist Heat or Steam Sterilization

[00840185305305]

Moist Heat or Steam Sterilization

[00840185305305]

Moist Heat or Steam Sterilization

[00840185305305]

Moist Heat or Steam Sterilization

[00840185305305]

Moist Heat or Steam Sterilization

[00840185305305]

Moist Heat or Steam Sterilization

[00840185305305]

Moist Heat or Steam Sterilization

[00840185305305]

Moist Heat or Steam Sterilization

[00840185305305]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-05
Device Publish Date2021-03-27

On-Brand Devices [4CIS VERTU SPINE SYSTEM]

00840185314277Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.5 mm, 100 mm Length The Spinal Fixation Syst
00840185314260Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.5 mm, 95 mm Length The Spinal Fixation Syste
00840185314253Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.5 mm, 90 mm Length The Spinal Fixation Syste
00840185314246Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.5 mm, 85 mm Length The Spinal Fixation Syste
00840185314239Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.5 mm, 80 mm Length The Spinal Fixation Syste
00840185314222Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.5 mm, 75 mm Length The Spinal Fixation Syste
00840185314215Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.5 mm, 70 mm Length The Spinal Fixation Syste
00840185314208Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.5 mm, 65 mm Length The Spinal Fixation Syste
00840185314192Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.5 mm, 60 mm Length The Spinal Fixation Syste
00840185314185Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.5 mm, 55 mm Length The Spinal Fixation Syste
00840185314178Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.5 mm, 50 mm Length The Spinal Fixation Syste
00840185314161Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.5 mm, 45 mm Length The Spinal Fixation Syste
00840185314154Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.5 mm, 40 mm Length The Spinal Fixation Syste
00840185314147Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.5 mm, 35 mm Length The Spinal Fixation Syste
00840185314116Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.0 mm, 100 mm Length The Spinal Fixation Syst
00840185314109Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.0 mm, 95 mm Length The Spinal Fixation Syste
00840185314093Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.0 mm, 90 mm Length The Spinal Fixation Syste
00840185314086Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.0 mm, 85 mm Length The Spinal Fixation Syste
00840185314079Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.0 mm, 80 mm Length The Spinal Fixation Syste
00840185314062Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.0 mm, 75 mm Length The Spinal Fixation Syste
00840185314055Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.0 mm, 70 mm Length The Spinal Fixation Syste
00840185314048Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.0 mm, 65 mm Length The Spinal Fixation Syste
00840185314031Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.0 mm, 60 mm Length The Spinal Fixation Syste
00840185314024Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.0 mm, 55 mm Length The Spinal Fixation Syste
00840185314017Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.0 mm, 50 mm Length The Spinal Fixation Syste
00840185314000Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.0 mm, 45 mm Length The Spinal Fixation Syste
00840185313997Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.0 mm, 40 mm Length The Spinal Fixation Syste
00840185313980Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.0 mm, 35 mm Length The Spinal Fixation Syste
00840185313959Mono-axial Reduction Cannulated Pedicle Screw, Ø 6.5 mm, 100 mm Length The Spinal Fixation Syst
00840185313942Mono-axial Reduction Cannulated Pedicle Screw, Ø 6.5 mm, 95 mm Length The Spinal Fixation Syste
00840185313935Mono-axial Reduction Cannulated Pedicle Screw, Ø 6.5 mm, 90 mm Length The Spinal Fixation Syste
00840185313928Mono-axial Reduction Cannulated Pedicle Screw, Ø 6.5 mm, 85 mm Length The Spinal Fixation Syste
00840185313911Mono-axial Reduction Cannulated Pedicle Screw, Ø 6.5 mm, 80 mm Length The Spinal Fixation Syste
00840185313904Mono-axial Reduction Cannulated Pedicle Screw, Ø 6.5 mm, 75 mm Length The Spinal Fixation Syste
00840185313898Mono-axial Reduction Cannulated Pedicle Screw, Ø 6.5 mm, 70 mm Length The Spinal Fixation Syste
00840185313881Mono-axial Reduction Cannulated Pedicle Screw, Ø 6.5 mm, 65 mm Length The Spinal Fixation Syste
00840185313874Mono-axial Reduction Cannulated Pedicle Screw, Ø 6.5 mm, 60 mm Length The Spinal Fixation Syste
00840185313867Mono-axial Reduction Cannulated Pedicle Screw, Ø 6.5 mm, 55 mm Length The Spinal Fixation Syste
00840185313850Mono-axial Reduction Cannulated Pedicle Screw, Ø 6.5 mm, 50 mm Length The Spinal Fixation Syste
00840185313843Mono-axial Reduction Cannulated Pedicle Screw, Ø 6.5 mm, 45 mm Length The Spinal Fixation Syste
00840185313836Mono-axial Reduction Cannulated Pedicle Screw, Ø 6.5 mm, 40 mm Length The Spinal Fixation Syste
00840185313829Mono-axial Reduction Cannulated Pedicle Screw, Ø 6.5 mm, 35 mm Length The Spinal Fixation Syste
00840185313553Mono-axial Cannulated Pedicle Screw, Ø 7.5 mm, 100 mm Length The Spinal Fixation System is a to
00840185313546Mono-axial Cannulated Pedicle Screw, Ø 7.5 mm, 95 mm Length The Spinal Fixation System is a top
00840185313539Mono-axial Cannulated Pedicle Screw, Ø 7.5 mm, 90 mm Length The Spinal Fixation System is a top
00840185313522Mono-axial Cannulated Pedicle Screw, Ø 7.5 mm, 85 mm Length The Spinal Fixation System is a top
00840185313515Mono-axial Cannulated Pedicle Screw, Ø 7.5 mm, 80 mm Length The Spinal Fixation System is a top
00840185313508Mono-axial Cannulated Pedicle Screw, Ø 7.5 mm, 75 mm Length The Spinal Fixation System is a top
00840185313492Mono-axial Cannulated Pedicle Screw, Ø 7.5 mm, 70 mm Length The Spinal Fixation System is a top
00840185313485Mono-axial Cannulated Pedicle Screw, Ø 7.5 mm, 65 mm Length The Spinal Fixation System is a top
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