SHRIRAM INSTITUTE FOR INDUSTRIAL RESEARCH

FDA Device Registration & Listing · Delhi, IN · Registration 3002808145

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3002808145
FEI Number
3002808145
Entity Name
SHRIRAM INSTITUTE FOR INDUSTRIAL RESEARCH
City/State/Country
Delhi, IN
Establishment Address
SHRIRAM APPLIED RADIATION CENTRE, 19, UNIVERSITY ROAD, Delhi 110007, IN
Establishment Type(s)
Sterilize Medical Device for Another Party (Contract Sterilizer)
Owner / Operator
SHRIRAM INSTITUTE FOR INDUSTRIAL RESEARCH (Owner Number: 10051684)
Owner / Operator Contact Address
SHRIRAM APPLIED RADIATION CENTRE, 19, UNIVERSITY ROAD, Delhi, IN-DL 110007, IN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

AV-Wiselock Elbow System Clavicle and Scapula System 2.4mm Distal Radius System Auxein's DHS-DCS Plate System Auxein Nailing System (Sterile) Auxein Brand Vertaux 5.5mm Pedicle Screw System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-01-06
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-01-06
GDX Scalpel, One-Piece General, Plastic Surgery Class 1 878.4800 2016-05-10
GES Blade, Scalpel General, Plastic Surgery Class 1 878.4800 2016-05-05
FZS Curette, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2016-05-05
HNN Knife, Ophthalmic Ophthalmic Class 1 886.4350 2016-05-05
GFD Dermatome General, Plastic Surgery Class 1 878.4820 2016-05-05
FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2016-05-05
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-01-06
EME Punch, Biopsy, Surgical Dental Class 1 872.4565 2016-04-20
FZT Cutter, Surgical General, Plastic Surgery Class 1 878.4800 2016-05-05
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-01-06
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-01-06
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-01-06
KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component Orthopedic Class 2 888.3030 2025-01-06
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-01-06
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2025-01-06
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2025-01-06
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-01-06
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-01-06
GDZ Handle, Scalpel General, Plastic Surgery Class 1 878.4800 2016-05-05

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

SHRIRAM INSTITUTE FOR INDUSTRIAL RESEARCH
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
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08
K063244 Arc Surgical, LLC ARC SURGICAL BONE REDUCTION SCREW 2006-12-27
K972722 Orthopedic Designs, Inc. ULTIMATE COMPRESSION SCREW SYSTEM 1998-01-23
K192974 Tyber Medical, LLC Tyber Medical Trauma Screw 2020-01-08
K082949 OrthoPediatrics Corp. ORTHOPEDIATRICS BONE SCREWS 2008-11-25

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0014-2014 Synthes USA HQ, Inc. 2
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016 Ortho Solutions Inc 330 Franklin Tnpk 2
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0043-2018 MicroPort Orthopedics Inc. 2
MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002808145. Last updated year: 2026. Please use registration number 3002808145 when referencing this establishment in official correspondence.
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