FDA.reportPublic FDA data

4CIS SARA/VERTU SPINE SYSTEM

Primary DI
00840185382139
Brand
4CIS SARA/VERTU SPINE SYSTEM
Company
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
Model
AISP-1517-5501
Catalog number
1517-5501
Device description
Rod: Ø 5.5 mm, Length 55 mm , Straight end,Make: Titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F136
Published
2026-05-16
Public version status
New
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
00840185382139PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840185382139008401853821398401853821390840185382139

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, 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 stabilization device (e.g., rod, plate) to bone; it is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used in spinal discectomy and fusion procedures as a means to maintain the relative position of bone allografts or autografts.

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
00197157075835ZAVATION DRIVERZavation LLCNKB2026-05-27
00197157075842ZAVATION K-WIREZavation LLCNKB2026-05-27
06009699901715Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-27
06009699901722Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-27
00810088650970Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651052Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651144Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651151Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651168Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651175Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651182Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651366Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651373Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651380Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651397Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651403Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651588Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651595Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651601Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651618Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651625Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651632Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651809Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651816Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651823Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651830Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651847Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651854Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088652035Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088652042Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12