FDA.reportPublic FDA data

4CIS DOLPHIN TLIF CAGE SYSTEM

Primary DI
00840185327963
Brand
4CIS DOLPHIN TLIF CAGE SYSTEM
Company
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
Model
AIIN-0105-0136
Catalog number
0105-0136
Device description
Funnel Impactor
Published
2026-05-29
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213653000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K2136530004CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEMSolco Biomedical Company India Private Limited2022-12-19MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840185327963PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840185327963008401853279638401853279630840185327963

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
DM exempt
false
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
true
No natural rubber latex
false
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
00840606185110LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185127LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185134LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185141LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185158LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185165LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606196024VertuSPINAL ELEMENTS, INC.MAX2026-09-25
00840606196031VertuSPINAL ELEMENTS, INC.MAX2026-09-25
00840606196048VertuSPINAL ELEMENTS, INC.MAX2026-09-25
00810017915170SABER-XA, Screw Ø5.5 x 32.5ELEVATION SPINE, INC.MAX2026-09-22
10888857461819CASCADIA™ Interbody SystemVB Spine LLCMAX2019-10-31
10888857461888CASCADIA™ Interbody SystemVB Spine LLCMAX2019-10-31
04546540665720AVS NAVIGATORStryker CorporationMAX2016-09-24
10888857218772CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857218963CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857219076CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857219489CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857219595CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
07613153046196AVS PLStryker CorporationMAX2015-09-14
07613153046202AVS PLStryker CorporationMAX2015-09-14
07613153046219AVS PLStryker CorporationMAX2015-09-14
07613153046226AVS PLStryker CorporationMAX2015-09-14
07613153046233AVS PLStryker CorporationMAX2015-09-14
07613153046288AVS PLStryker CorporationMAX2015-09-14
07613153046295AVS PLStryker CorporationMAX2015-09-14
07613153046301AVS PLStryker CorporationMAX2015-09-14
07613153046318AVS PLStryker CorporationMAX2015-09-14
07613153046325AVS PLStryker CorporationMAX2015-09-14
07613153046332AVS PLStryker CorporationMAX2015-09-14
07613153046349AVS PLStryker CorporationMAX2015-09-14