FDA.reportPublic FDA data

4CIS SARA SPINE SYSTEM

Primary DI
00840185300560
Brand
4CIS SARA SPINE SYSTEM
Company
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
Model
AISP-1012-6545
Catalog number
1012-6545
Device description
Poly-axial Pedicle Screw, Ø6.5 mm , 45 mm Length
Published
2021-03-26
Public version status
Update
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
K202498000
K232607000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K2024980004CIS SARA Spine System, 4CIS VERTU Spine SystemSolco Biomedical Company India Private Limited2021-02-18NKB
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
00840185300560PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840185300560008401853005608401853005600840185300560

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
868354728
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840466901011PrimusSPINAL ELEMENTS, INC.NKB2026-10-22
00840606174855PrimusSPINAL ELEMENTS, INC.NKB2026-10-22
00840606175142PrimusSPINAL ELEMENTS, INC.NKB2026-10-22
00840606175203PrimusSPINAL ELEMENTS, INC.NKB2026-10-22
00840606185868PrimusSPINAL ELEMENTS, INC.NKB2026-10-22
03701313009823KHEIRONS.M.A.I.ONKB2026-10-22
03701313009830KHEIRONS.M.A.I.ONKB2026-10-22
03701313009854KHEIRONS.M.A.I.ONKB2026-10-22
03701313009878KHEIRONS.M.A.I.ONKB2026-10-22
03701313009885KHEIRONS.M.A.I.ONKB2026-10-22
03701313009892KHEIRONS.M.A.I.ONKB2026-10-22
03701313009908KHEIRONS.M.A.I.ONKB2026-10-22
00197157123611ZAVATION SCREWZavation LLCNKB2026-10-21
00197157123628ZAVATION SCREWZavation LLCNKB2026-10-21
00197157123635ZAVATION SCREWZavation LLCNKB2026-10-21
00197157123642ZAVATION SCREWZavation LLCNKB2026-10-21
00197157123659ZAVATION SCREWZavation LLCNKB2026-10-21
00197157123666ZAVATION SCREWZavation LLCNKB2026-10-21
00197157122874ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122881ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122898ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122904ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122911ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122928ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122935ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122942ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122959ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122966ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122973ZAVATION SCREWZavation LLCNKB2026-10-20
00197157122980ZAVATION SCREWZavation LLCNKB2026-10-20