FDA.reportPublic FDA data

4CIS WILL PEDICLE SCREW SYSTEM

Primary DI
00840185382566
Brand
4CIS WILL PEDICLE SCREW SYSTEM
Company
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
Model
AIIN-0114-0041
Catalog number
0114-0041
Device description
Cannulated In-line Handle
Published
2026-05-25
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
00840185382566PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840185382566008401853825668401853825660840185382566

GMDN Terms#

Term, Definition table
TermDefinition
Internal spinal fixation procedure kit, reusableA collection of various orthopaedic manual surgical instruments (e.g., screwdriver, trial rod, adaptor, mallet, guide tube, chisel, rasp, awl, burr, tap, drill) intended to be used to perform a bone-screw internal spinal fixation and/or spinal fusion cage implantation procedure (including stereotactic procedures); implanted devices are not included. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
868354728
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
008401853725434CIS WILL PEDICLE SCREW SYSTEMAISP-1526-55751526-55752026-05-20
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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