FDA.reportPublic FDA data

4CIS WILL PEDICLE SCREW SYSTEM

Primary DI
00840185372543
Brand
4CIS WILL PEDICLE SCREW SYSTEM
Company
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
Model
AISP-1526-5575
Catalog number
1526-5575
Device description
The 4CIS WILL Pedicle Screw System is a minimally invasive spinal fixation device used to stabilize the thoracic and lumbar spine during fusion surgery. It consists of polyaxial, cannulated pedicle screws, rods, and set screws, allowing percutaneous insertion with minimal tissue damage.
Published
2026-05-20
Public version status
New
Distribution status
Not 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
K232607000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K2326070004CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEMSolco Biomedical Copany India Private Limited2024-02-27NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840185372543PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840185372543008401853725438401853725430840185372543

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length75Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
868354728
Device count
1
Combination product
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008401853825664CIS WILL PEDICLE SCREW SYSTEMAIIN-0114-00410114-00412026-05-25
008401853825734CIS WILL PEDICLE SCREW SYSTEMAIIN-0114-00420114-00422026-05-25
008401853825804CIS WILL PEDICLE SCREW SYSTEMAIIN-0114-00430114-00432026-05-25
008401853825974CIS WILL PEDICLE SCREW SYSTEMAIIN-0114-00440114-00442026-05-25
008401853653164CIS WILL PEDICLE SCREW SYSTEMAISP-1526-55601526-55602026-05-19
008401853653474CIS WILL PEDICLE SCREW SYSTEMAISP-1526-55111526-55112026-05-19
008401853653544CIS WILL PEDICLE SCREW SYSTEMAISP-1526-55131526-55132026-05-19
008401853653614CIS WILL PEDICLE SCREW SYSTEMAISP-1526-55151526-55152026-05-19
008401853653784CIS WILL PEDICLE SCREW SYSTEMAISP-1526-55171526-55172026-05-19
008401853653854CIS WILL PEDICLE SCREW SYSTEMAISP-1526-55191526-55192026-05-19
008401853725294CIS WILL PEDICLE SCREW SYSTEMAISP-1526-55551526-55552026-05-19
008401853652554CIS WILL PEDICLE SCREW SYSTEMAISP-1527-55011527-55012026-05-18
008401853652864CIS WILL PEDICLE SCREW SYSTEMAISP-1527-55041527-55042026-05-18
008401853825044CIS WILL PEDICLE SCREW SYSTEMAISP-1527-55181527-55182026-05-18
008401853825114CIS WILL PEDICLE SCREW SYSTEMAISP-1527-55231527-55232026-05-18
008401853825284CIS WILL PEDICLE SCREW SYSTEMAIIN-0114-00050114-00052026-05-18
008401853825354CIS WILL PEDICLE SCREW SYSTEMAIIN-0114-01530114-01532026-05-18
008401853825424CIS WILL PEDICLE SCREW SYSTEMAICN-1001-01121001-01122026-05-18
008401853825594CIS WILL PEDICLE SCREW SYSTEMAICN-1003-00011003-00012026-05-18
008401853653924CIS SARA/VERTU SPINE SYSTEMAISP-1517-55011517-55012026-05-16

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