FDA.reportPublic FDA data

4CIS SARA SPINE SYSTEM

Primary DI
00840185308528
Brand
4CIS SARA SPINE SYSTEM
Company
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
Model
AISP-2801-6560
Catalog number
2801-6560
Device description
Poly-axial Cannulated Pedicle Screw, Ø6.5 mm, 60 mm Length
Published
2021-03-26
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
00840185308528PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840185308528008401853085288401853085280840185308528

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
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
07290115935578PER Trial 60PREMIA SPINE LTDNKB2026-07-22
07290115935691PER Trial 50PREMIA SPINE LTDNKB2026-07-22
00840466901035PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901042PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901059PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901066PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901073PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901080PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901097PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901103PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901110PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901127PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901141PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901158PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901165PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901172PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901479PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901486PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901493PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901509PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901516PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901523PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901530PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901547PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901554PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901561PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901578PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901585PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901592PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901608PrimusSPINAL ELEMENTS, INC.NKB2026-07-21