4CIS VERTU SPINE SYSTEM

Primary DI
00840185304421
Brand
4CIS VERTU SPINE SYSTEM
Company
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
Model
AISP-1035-7035
Catalog number
1035-7035
Device description
Poly-axial Pedicle Screw, Ø mm : 7.0, Length mm: 35The 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
Published
2021-03-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202498000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K2024980004CIS SARA Spine System, 4CIS VERTU Spine SystemSolco Biomedical Company India Private Limited2021-02-18NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840185304421PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840185304421008401853044218401853044210840185304421

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
868354728
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840185383495DOLPHIN TLIF CAGE TRIAL, 4CIS DOLPHIN TLIF CAGE SYSTEMAIIN-0105-08540105-08542026-09-29
00840185383501DOLPHIN TLIF CAGE TRIAL, 4CIS DOLPHIN TLIF CAGE SYSTEMAIIN-0105-08550105-08552026-09-29
00840185383518DOLPHIN TLIF CAGE TRIAL, 4CIS DOLPHIN TLIF CAGE SYSTEMAIIN-0105-08560105-08562026-09-29
00840185383525DOLPHIN TLIF CAGE TRIAL, 4CIS DOLPHIN TLIF CAGE SYSTEMAIIN-0105-08570105-08572026-09-29
00840185383532DOLPHIN TLIF CAGE TRIAL, 4CIS DOLPHIN TLIF CAGE SYSTEMAIIN-0105-08580105-08582026-09-29
00840185383549DOLPHIN TLIF CAGE TRIAL, 4CIS DOLPHIN TLIF CAGE SYSTEMAIIN-0105-08590105-08592026-09-29
00840185383556DOLPHIN TLIF CAGE TRIAL, 4CIS DOLPHIN TLIF CAGE SYSTEMAIIN-0105-08600105-08602026-09-29
00840185383563DOLPHIN TLIF CAGE TRIAL, 4CIS DOLPHIN TLIF CAGE SYSTEMAIIN-0105-08700105-08702026-09-29
00840185383570DOLPHIN TLIF CAGE TRIAL, 4CIS DOLPHIN TLIF CAGE SYSTEMAIIN-0105-08710105-08712026-09-29
00840185383587DOLPHIN TLIF CAGE TRIAL, 4CIS DOLPHIN TLIF CAGE SYSTEMAIIN-0105-08720105-08722026-09-29
00840185383594DOLPHIN TLIF CAGE TRIAL, 4CIS DOLPHIN TLIF CAGE SYSTEMAIIN-0105-08730105-08732026-09-29
00840185383600DOLPHIN TLIF CAGE TRIAL, 4CIS DOLPHIN TLIF CAGE SYSTEMAIIN-0105-08740105-08742026-09-29
00840185383617DOLPHIN TLIF CAGE TRIAL, 4CIS DOLPHIN TLIF CAGE SYSTEMAIIN-0105-08750105-08752026-09-29
00840185383624DOLPHIN TLIF CAGE TRIAL, 4CIS DOLPHIN TLIF CAGE SYSTEMAIIN-0105-08760105-08762026-09-29
008401853005534CIS SARA SPINE SYSTEMAISP-1012-65401012-65402021-03-26
008401853005604CIS SARA SPINE SYSTEMAISP-1012-65451012-65452021-03-26
008401853005774CIS SARA SPINE SYSTEMAISP-1012-65501012-65502021-03-26
008401853005844CIS SARA SPINE SYSTEMAISP-1012-65551012-65552021-03-26
008401853273524CIS DOLPHIN TLIF CAGE SYSTEMAIIN-0105-02140105-02142026-05-29
008401853273694CIS DOLPHIN TLIF CAGE SYSTEMAIIN-0105-01340105-01342026-05-29

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