FDA.reportPublic FDA data

4CIS DOLPHIN TLIF CAGE SYSTEM

Primary DI
00840185327499
Brand
4CIS DOLPHIN TLIF CAGE SYSTEM
Company
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
Model
AIIN-0105-0127
Catalog number
0105-0127
Device description
Sharp Reamer
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
00840185327499PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840185327499008401853274998401853274990840185327499

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Diameter 11.0mm

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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606176347LucentSPINAL ELEMENTS, INC.MAX2026-10-22
00840606184847LucentSPINAL ELEMENTS, INC.MAX2026-10-22
00840606197106LucentSPINAL ELEMENTS, INC.MAX2026-10-22
B648C29510000Savant Lumbar Interbody Fusion SystemCURITEVA, INC.MAX2026-10-19
M719GLL11403DP Lumbar Interbody SystemGenesys Orthopedics Systems LLCMAX2026-10-19
M719GLL11503DP Lumbar Interbody SystemGenesys Orthopedics Systems LLCMAX2026-10-19
M719GLL11603DP Lumbar Interbody SystemGenesys Orthopedics Systems LLCMAX2026-10-19
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00810161900558EARP, 18X30X12 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
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00810161900602EARP, 18X35X14 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16