FDA.reportPublic FDA data

4CIS WILL PEDICLE SCREW SYSTEM

Primary DI
00840185382290
Brand
4CIS WILL PEDICLE SCREW SYSTEM
Company
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
Model
AIIN-0114-0009
Catalog number
0114-0009
Device description
Outer Distractor
Published
2026-05-17
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
00840185382290PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840185382290008401853822908401853822900840185382290

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.

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
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
008401853273764CIS DOLPHIN TLIF CAGE SYSTEMAIIN-0105-01050105-01052026-05-29
008401853273834CIS DOLPHIN TLIF CAGE SYSTEMAIIN-0105-01060105-01062026-05-29
008401853273904CIS DOLPHIN TLIF CAGE SYSTEMAIIN-0105-01070105-01072026-05-29
008401853274064CIS DOLPHIN TLIF CAGE SYSTEMAIIN-0105-01080105-01082026-05-29
008401853274134CIS DOLPHIN TLIF CAGE SYSTEMAIIN-0105-01090105-01092026-05-29
008401853274204CIS DOLPHIN TLIF CAGE SYSTEMAIIN-0105-01100105-01102026-05-29
008401853274374CIS DOLPHIN TLIF CAGE SYSTEMAIIN-0105-01110105-01112026-05-29
008401853274444CIS DOLPHIN TLIF CAGE SYSTEMAIIN-0105-01120105-01122026-05-29
008401853274514CIS DOLPHIN TLIF CAGE SYSTEMAIIN-0105-01230105-01232026-05-29
008401853274684CIS DOLPHIN TLIF CAGE SYSTEMAIIN-0105-01240105-01242026-05-29
008401853274754CIS DOLPHIN TLIF CAGE SYSTEMAIIN-0105-01250105-01252026-05-29
008401853274824CIS DOLPHIN TLIF CAGE SYSTEMAIIN-0105-01260105-01262026-05-29
008401853274994CIS DOLPHIN TLIF CAGE SYSTEMAIIN-0105-01270105-01272026-05-29
008401853275054CIS DOLPHIN TLIF CAGE SYSTEMAIIN-0105-01280105-01282026-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-06-28
10889981441555VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441609VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441616VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441623VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441661VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981065348MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065539MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065553MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065577MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065584MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065607MarinerSeaspine Orthopedics CorporationNKB2016-09-02
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10889981065669MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065683MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065706MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065720MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065744MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065768MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065782MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065805MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065829MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065843MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065867MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065881MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065904MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065928MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065959MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065966MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065973MarinerSeaspine Orthopedics CorporationNKB2016-09-02