BRM EXTREMITIES SRL

FDA Device Registration & Listing · Civate (LC) Lombardy, IT · Registration 3016669046

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
3016669046
FEI Number
3016669046
Entity Name
BRM EXTREMITIES SRL
City/State/Country
Civate (LC) Lombardy, IT
Establishment Address
Via Privata ai Campi, 7, Civate (LC) Lombardy 23862, IT
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
BRM EXTREMITIES (Owner Number: 10062707)
Owner / Operator Contact Address
Via Lorenzo Mascheroni, 29, Milano, IT-25 20145, IT
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Percutaneous Burrs BRM TOOL VIP SCREWS BRM VR BREAKING SCREWS BRM TOOL SCREWS BRM TOOL PRO 7 SCREWS Silktoe Instruments BRM VR Breaking Screws Instruments Digitalis Instruments Tool Instruments Tool Pro Instruments Tool Vip Instruments BioPlan Instruments BRM DRILL BIT

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HTT Burr, Orthopedic Orthopedic Class 1 888.4540 2020-03-10
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-11-17
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2020-03-10
HTW Bit, Drill Orthopedic Class 1 888.4540 2025-04-04

Official Correspondent

Lisa Fazzini

US Agent Details

Margeaux Rogers Business: MCRA, LLC Email: mrogers@mcra.com Phone: (202) 5525805

Related Public Records

Same Entity

BRM EXTREMITIES
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

Similar Registrations

Registration Number Establishment Name Location
3006017180 BBF STERILISATIONSSERVICE GMBH Kernen Baden-Wurttemberg, DE
2025102 Brasseler U.S.A. Medical, LLC Savannah, GA, US
3005575604 SURETEK MEDICAL GREENVILLE, SC, US
3038195984 BEIJING FULE SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD. Beijing, CN
3014334038 Integra LifeSciences Production Corporation Mansfield, MA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016669046. Last updated year: 2026. Please use registration number 3016669046 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.