SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3016443334	3016443334	SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED	1	N	2026-01-01	SURVEY NO-1540, BESIDE TORRENT PHARMA, AHMEDABD-MEHSANA HIGHWAY, VILLAGE-RAJPUR KADI Gujarat IN 382715

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
279441	1939136331	K242141	TiLink-P SI Joint Fusion System	OUR	2024-08-21
279441	1037389829	K232607	4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM	NKB	2024-02-27
279441	1009851183	K213653	4CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEM	MAX	2022-12-19
279441	1247370885	K202498	4CIS SARA Spine System, 4CIS VERTU Spine System	NKB	2021-02-18
279441	1004874865
279441	1015543217
279441	1044232007
279441	1055931518
279441	1064729623
279441	1071924707
279441	1073323249
279441	1084534837
279441	1098900640
279441	1107348499
279441	1133134624
279441	1136288698
279441	1139587258
279441	1140006133
279441	1173099274
279441	1202689445
279441	1210660895
279441	1215017885
279441	1222761097
279441	1244497026
279441	1254124272
279441	1334373182
279441	1341879151
279441	1366170954
279441	1380784390
279441	1383018360
279441	1405808544
279441	1417987581
279441	1429469639
279441	1434199798
279441	1442082839
279441	1446988341
279441	1447112625
279441	1496611260
279441	1500298763
279441	1508774308
279441	1520101414
279441	1556794331
279441	1571347367
279441	1575001134
279441	1605222663
279441	1606787271
279441	1621886770
279441	1650033681
279441	1659365901
279441	1673332549
279441	1697995961
279441	1715987801
279441	1761145322
279441	1832309936
279441	1835783451
279441	1876270439
279441	1889472451
279441	1891597918
279441	1892054987
279441	1900791975
279441	1906900052
279441	1908665559
279441	1915540531
279441	1927877227
279441	1957659665
279441	1981833577
279441	1993325219
279441	1994481901
279441	1998255015
279441	2043231710
279441	2073578479

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
NKB	2	2024-02-27
OUR	1	2024-08-21
MAX	1	2022-12-19

PMN#

4CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEM
2022-12-19
Solco Biomedical Company India Private Limited
4CIS SARA Spine System, 4CIS VERTU Spine System
2021-02-18
Solco Biomedical Company India Private Limited

GUDID#

DOLPHIN TLIF CAGE TRIAL, 4CIS DOLPHIN TLIF CAGE SYSTEM - DOLPHIN TLIF CAGE is used during transforaminal lumbar interbody fusion (TLIF) procedures to assess the appropriate size and positioning of the corresponding DOLPHIN TLIF Cage prior to implantation. It is used to aid in determining the suitable implant size and fit within the intervertebral disc space.
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
2026-09-29
DOLPHIN TLIF CAGE TRIAL, 4CIS DOLPHIN TLIF CAGE SYSTEM - DOLPHIN TLIF CAGE is used during transforaminal lumbar interbody fusion (TLIF) procedures to assess the appropriate size and positioning of the corresponding DOLPHIN TLIF Cage prior to implantation. It is used to aid in determining the suitable implant size and fit within the intervertebral disc space.
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
2026-09-29
DOLPHIN TLIF CAGE TRIAL, 4CIS DOLPHIN TLIF CAGE SYSTEM - DOLPHIN TLIF CAGE is used during transforaminal lumbar interbody fusion (TLIF) procedures to assess the appropriate size and positioning of the corresponding DOLPHIN TLIF Cage prior to implantation. It is used to aid in determining the suitable implant size and fit within the intervertebral disc space.
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
2026-09-29
DOLPHIN TLIF CAGE TRIAL, 4CIS DOLPHIN TLIF CAGE SYSTEM - DOLPHIN TLIF CAGE is used during transforaminal lumbar interbody fusion (TLIF) procedures to assess the appropriate size and positioning of the corresponding DOLPHIN TLIF Cage prior to implantation. It is used to aid in determining the suitable implant size and fit within the intervertebral disc space.
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
2026-09-29
DOLPHIN TLIF CAGE TRIAL, 4CIS DOLPHIN TLIF CAGE SYSTEM - DOLPHIN TLIF CAGE is used during transforaminal lumbar interbody fusion (TLIF) procedures to assess the appropriate size and positioning of the corresponding DOLPHIN TLIF Cage prior to implantation. It is used to aid in determining the suitable implant size and fit within the intervertebral disc space.
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
2026-09-29
DOLPHIN TLIF CAGE TRIAL, 4CIS DOLPHIN TLIF CAGE SYSTEM - DOLPHIN TLIF CAGE is used during transforaminal lumbar interbody fusion (TLIF) procedures to assess the appropriate size and positioning of the corresponding DOLPHIN TLIF Cage prior to implantation. It is used to aid in determining the suitable implant size and fit within the intervertebral disc space.
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
2026-09-29
DOLPHIN TLIF CAGE TRIAL, 4CIS DOLPHIN TLIF CAGE SYSTEM - DOLPHIN TLIF CAGE is used during transforaminal lumbar interbody fusion (TLIF) procedures to assess the appropriate size and positioning of the corresponding DOLPHIN TLIF Cage prior to implantation. It is used to aid in determining the suitable implant size and fit within the intervertebral disc space.
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
2026-09-29
DOLPHIN TLIF CAGE TRIAL, 4CIS DOLPHIN TLIF CAGE SYSTEM - DOLPHIN TLIF CAGE is used during transforaminal lumbar interbody fusion (TLIF) procedures to assess the appropriate size and positioning of the corresponding DOLPHIN TLIF Cage prior to implantation. It is used to aid in determining the suitable implant size and fit within the intervertebral disc space.
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
2026-09-29
DOLPHIN TLIF CAGE TRIAL, 4CIS DOLPHIN TLIF CAGE SYSTEM - DOLPHIN TLIF CAGE is used during transforaminal lumbar interbody fusion (TLIF) procedures to assess the appropriate size and positioning of the corresponding DOLPHIN TLIF Cage prior to implantation. It is used to aid in determining the suitable implant size and fit within the intervertebral disc space.
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
2026-09-29
DOLPHIN TLIF CAGE TRIAL, 4CIS DOLPHIN TLIF CAGE SYSTEM - DOLPHIN TLIF CAGE is used during transforaminal lumbar interbody fusion (TLIF) procedures to assess the appropriate size and positioning of the corresponding DOLPHIN TLIF Cage prior to implantation. It is used to aid in determining the suitable implant size and fit within the intervertebral disc space.
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
2026-09-29
DOLPHIN TLIF CAGE TRIAL, 4CIS DOLPHIN TLIF CAGE SYSTEM - DOLPHIN TLIF CAGE is used during transforaminal lumbar interbody fusion (TLIF) procedures to assess the appropriate size and positioning of the corresponding DOLPHIN TLIF Cage prior to implantation. It is used to aid in determining the suitable implant size and fit within the intervertebral disc space.
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
2026-09-29
DOLPHIN TLIF CAGE TRIAL, 4CIS DOLPHIN TLIF CAGE SYSTEM - DOLPHIN TLIF CAGE is used during transforaminal lumbar interbody fusion (TLIF) procedures to assess the appropriate size and positioning of the corresponding DOLPHIN TLIF Cage prior to implantation. It is used to aid in determining the suitable implant size and fit within the intervertebral disc space.
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
2026-09-29
DOLPHIN TLIF CAGE TRIAL, 4CIS DOLPHIN TLIF CAGE SYSTEM - DOLPHIN TLIF CAGE is used during transforaminal lumbar interbody fusion (TLIF) procedures to assess the appropriate size and positioning of the corresponding DOLPHIN TLIF Cage prior to implantation. It is used to aid in determining the suitable implant size and fit within the intervertebral disc space.
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
2026-09-29
DOLPHIN TLIF CAGE TRIAL, 4CIS DOLPHIN TLIF CAGE SYSTEM - DOLPHIN TLIF CAGE is used during transforaminal lumbar interbody fusion (TLIF) procedures to assess the appropriate size and positioning of the corresponding DOLPHIN TLIF Cage prior to implantation. It is used to aid in determining the suitable implant size and fit within the intervertebral disc space.
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
2026-09-29
4CIS SARA SPINE SYSTEM - Poly-axial Pedicle Screw, Ø6.5 mm , 40 mm Length
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
2021-03-26
4CIS SARA SPINE SYSTEM - Poly-axial Pedicle Screw, Ø6.5 mm , 45 mm Length
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
2021-03-26
4CIS SARA SPINE SYSTEM - Poly-axial Pedicle Screw, Ø6.5 mm , 50 mm Length
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
2021-03-26
4CIS SARA SPINE SYSTEM - Poly-axial Pedicle Screw, Ø6.5 mm , 55 mm Length
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
2021-03-26
4CIS DOLPHIN TLIF CAGE SYSTEM - TLIF Cage Holder
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
2026-05-29
4CIS DOLPHIN TLIF CAGE SYSTEM - TLIF Cage Holder
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
2026-05-29
4CIS DOLPHIN TLIF CAGE SYSTEM - Sharp Reamer
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
2026-05-29
4CIS DOLPHIN TLIF CAGE SYSTEM - Sharp Reamer
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
2026-05-29
4CIS DOLPHIN TLIF CAGE SYSTEM - Sharp Reamer
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
2026-05-29
4CIS DOLPHIN TLIF CAGE SYSTEM - Sharp Reamer
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
2026-05-29
4CIS DOLPHIN TLIF CAGE SYSTEM - Sharp Reamer
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
2026-05-29
4CIS DOLPHIN TLIF CAGE SYSTEM - Sharp Reamer
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
2026-05-29
4CIS DOLPHIN TLIF CAGE SYSTEM - Sharp Reamer
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
2026-05-29
4CIS DOLPHIN TLIF CAGE SYSTEM - Sharp Reamer
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
2026-05-29
4CIS DOLPHIN TLIF CAGE SYSTEM - Sharp Reamer
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
2026-05-29
4CIS DOLPHIN TLIF CAGE SYSTEM - Sharp Reamer
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
2026-05-29
4CIS DOLPHIN TLIF CAGE SYSTEM - Sharp Reamer
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
2026-05-29
4CIS DOLPHIN TLIF CAGE SYSTEM - Sharp Reamer
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
2026-05-29
4CIS DOLPHIN TLIF CAGE SYSTEM - Sharp Reamer
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
2026-05-29
4CIS DOLPHIN TLIF CAGE SYSTEM - Sharp Reamer
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
2026-05-29
4CIS DOLPHIN TLIF CAGE SYSTEM - Sharp Reamer
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
2026-05-29
4CIS DOLPHIN TLIF CAGE SYSTEM - Sharp Reamer
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
2026-05-29
4CIS DOLPHIN TLIF CAGE SYSTEM - PLIF last impactor
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
2026-05-29
4CIS DOLPHIN TLIF CAGE SYSTEM - Graft Holder Assembly
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
2026-05-29
4CIS DOLPHIN TLIF CAGE SYSTEM - Plif Cage (Black Marlin) Trial
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
2026-05-29
4CIS DOLPHIN TLIF CAGE SYSTEM - Plif Cage (Black Marlin) Trial
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
2026-05-29

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