FDA.reportPublic FDA data

4CIS SARA/VERTU SPINE SYSTEM

Primary DI
00840185307477
Brand
4CIS SARA/VERTU SPINE SYSTEM
Company
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
Model
AISP-1507-5535
Catalog number
1507-5535
Device description
Rod: Ø 5.5 mm, Length 350 mm , Straight end,Make: Titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F136
Published
2021-03-30
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
00840185307477PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840185307477008401853074778401853074770840185307477

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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700780634583Erisma®-LPCLARIANCENKB2026-05-28
06009699900008Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900503Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900817Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900831Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900848Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900855Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900862Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900879Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900886Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900893Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900909Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900916Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900923Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900930Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900947Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900954Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900961Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900978Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900985Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900992Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901005Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901012Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901029Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901036Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901043Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901050Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901067Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901074Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901081Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28