Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3029826185

FEI Number

3029826185

Entity Name

SIGMA SURGICAL PRIVATE LIMITED

City/State/Country

AHMEDABAD Gujarat, IN

Establishment Address

SURVEY NO 1636/1, OPPOSITE BHARAT PETROLEUM PETROL PUMP KUHA,, DASKROI, AHMEDABAD Gujarat 382433, IN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SIGMA SURGICAL PRIVATE LIMITED (Owner Number: 10095113)

Owner / Operator Contact Address

SURVEY NO 1636/1, OPPOSITE BHARAT PETROLEUM PETROL PUMP KUHA,, DASKROI, AHMEDABAD, IN-GJ 382433, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Instruments For Large Fragment LC-BCP & BCP Set Modular Reduction Clamp Nail Removal Set Screw Removal Set Spinal Instrument Set Instruments For Small Fragment LC-BCP & BCP Set Complete Instrument set Instruments for AMP System Instrument Set For Hyper Interlocking Nail For Tibial Bone Instrument Set For Hyper Proximal Interlocking Nail For Femoral Bone Complete Instrument set For ACL/PCL Reconstruction Bi-polar Instrument Set

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2026-01-26
KIJ	Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2026-01-26

Official Correspondent

No official correspondent registered.

US Agent Details

Manoj Zacharias Business: Liberty Management Group Ltd. Email: office@libertymanagement.us Phone: (630) 2702921

Related Public Records

Same Entity

SIGMA SURGICAL PRIVATE LIMITED

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K933337	R & D Batteries, Inc.	R AND D BATTERY REPLACEMENT	1994-04-05
K873766	Bowen & Company, Inc.	STERNAL POWER AWL	1988-11-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

Similar Registrations

Registration Number	Establishment Name	Location
3018033084	NEXT GENERATION TOOLING INC	Akron, OH, US
3038207124	NATIVE ORTHOPAEDICS	Providence, RI, US
3027516563	STAR SPORTS MEDICINE CO., LTD.	Beijing, CN
3021574846	3D LOGICS LLC	Hillsboro, OR, US
3030089866	ORTOLOG MEDIKAL SANAYI VE TICARET A.S.	Yenimahalle Ankara, TR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3029826185. Last updated year: 2026. Please use registration number 3029826185 when referencing this establishment in official correspondence.