Data / Medical devices / India / Solco Biomedical Company India Private Limited

Solco Biomedical Company India Private Limited: FDA-registered device maker in KADI Gujarat, India, 4 510(k) clearances

Name: Solco Biomedical Company India Private Limited FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Solco Biomedical Company India Private Limited is registered with the FDA (registration 3016443334) in KADI Gujarat, India. It lists 45 device types. The FDA files 4 510(k) clearances under its listings, the newest dated August 21, 2024. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Solco Biomedical Company India Private Limited

FDA registration number: 3016443334
Address: Survey No-1540, Beside Torrent Pharma, Ahmedabd-Mehsana Highway, Village-Rajpur, KADI Gujarat, India, 382715
Owner or operator: SOLCO BIOMEDICAL CO (10077960)
Roles: Contract manufacturer, Contract sterilizer, Manufacturer
First device listed: October 7, 2020
Registered through: 2026
Brand names listed: 2 Hole Plate Lateral Grabber, 2 Hole Plate Lateral Grabber, Med, 4.5 mm Drill Bit-7 mm, 4CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEM, 4CIS SARA SPINE SYSTEM, 4CIS SARA SPINE SYTEM, 4CIS VERTU SPINE SYSTEM and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Arthroscopic	NBH	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Accessories, Fixation, Spinal Intervertebral Body	LYQ	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Appliance, Fixation, Spinal Interlaminal	KWP	2	Contract manufacturer	accessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral Body	KWQ	2	Contract manufacturer	accessdata.fda.gov
Applier, Cerclage	HXN	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Awl	HWJ	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Bender	HXW	1	Contract sterilizer, Manufacturer	accessdata.fda.gov
Bit, Drill	HTW	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Bone Mill	LYS	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Brace, Drill	HXY	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Component, Traction, Non-Invasive	KQZ	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Corkscrew	HWI	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Countersink	HWW	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Cutter, Wire	HXZ	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Dispenser, Cement	KIH	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Driver, Prosthesis	HWR	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
File	HTP	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Fork	HXE	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Gauge, Depth	HTJ	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Guide, Drill, Ligament	LXI	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Holder, Needle; Orthopedic	HXK	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Impactor	HWA	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Instrument, Bending Or Contouring	HXP	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Instrument, Cast Application/Removal, Manual	LGG	1	Manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Cervical	ODP	2	Contract manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Lumbar	MAX	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, Cervical	OVE	2	Contract manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, Lumbar	OVD	2	Contract manufacturer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Manufacturer	accessdata.fda.gov
Orthopedic Stereotaxic Instrument	OLO	2	Contract manufacturer	accessdata.fda.gov
Orthosis, Spinal Pedicle Fixation	MNI	2	Contract manufacturer	accessdata.fda.gov
Orthosis, Spondylolisthesis Spinal Fixation	MNH	2	Contract manufacturer	accessdata.fda.gov
Passer, Wire, Orthopedic	HXI	1	Manufacturer	accessdata.fda.gov
Pusher, Socket	HXO	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Rasp	HTR	1	Contract manufacturer	accessdata.fda.gov
Reamer	HTO	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Sacroiliac Joint Fixation	OUR	2	Manufacturer	accessdata.fda.gov
Screwdriver	HXX	1	Contract manufacturer	accessdata.fda.gov
Spinal Vertebral Body Replacement Device	MQP	2	Contract manufacturer	accessdata.fda.gov
Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene	NBY	2	Contract manufacturer	accessdata.fda.gov
Syringe, Piston	FMF	2	Contract manufacturer	accessdata.fda.gov
System, Facet Screw Spinal Device	MRW	U	Contract manufacturer	accessdata.fda.gov
Tap, Bone	HWX	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Template	HWT	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Thoracolumbosacral Pedicle Screw System	NKB	2	Contract manufacturer, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 21, 2024	K242141	TiLink-P SI Joint Fusion System	OUR	Substantially Equivalent	SurGenTec, LLC	accessdata.fda.gov
February 27, 2024	K232607	4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM	NKB	Substantially Equivalent	Solco Biomedical Copany India Private Limited	accessdata.fda.gov
December 19, 2022	K213653	4CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEM	MAX	Substantially Equivalent	Solco Biomedical Company India Private Limited	accessdata.fda.gov
February 18, 2021	K202498	4CIS SARA Spine System, 4CIS VERTU Spine System	NKB	Substantially Equivalent	Solco Biomedical Company India Private Limited	accessdata.fda.gov

Compare with other makers

Updated August 21, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.