FDA.reportPublic FDA data

BRM TOOL Titanium Screw

Primary DI
08057717554243
Brand
BRM TOOL Titanium Screw
Company
BRM EXTREMITIES SRL
Model
TOOL Ø 3.2 x 34
Catalog number
SOS132034PS
Published
2025-07-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203773000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203773000BRM TOOL ScrewsBrm Extremities Srl2022-01-14HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08057717554243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08057717554243080577175542438057717554243

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature, keep dry and away from humidity and direct sources of light and heat

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+3903411693087info@brm-extremities.com

Regulatory Flags#

DUNS number
435126746
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08053782781652Bioplan Instruments KitInstruments kit for the implant of BRM ExtremitiesKIT.BIOPLAN2026-08-18
08057717553635BRM BIOPLAN INSTRUMENTScrewdriver – BioplanSBPI1CI0012026-08-18
08057717553642BRM BIOPLAN INSTRUMENTExtractor Screwdriver - BioplanSBPI1CE0022026-08-18
08057717553659BRM BIOPLAN INSTRUMENTBioplan - Trial Size 7SBPI10P0072026-08-18
08057717553666BRM BIOPLAN INSTRUMENTBioplan - Trial Size 8SBPI10P0082026-08-18
08057717553673BRM BIOPLAN INSTRUMENTBioplan - Trial Size 9SBPI10P0092026-08-18
08057717553680BRM BIOPLAN INSTRUMENTBioplan - Trial Size 10SBPI10P0102026-08-18
08057717553697BRM BIOPLAN INSTRUMENTBioplan - Trial Size 11SBPI10P0112026-08-18
08057717553703BRM BIOPLAN INSTRUMENTBioplan - Trial Size 12SBPI10P0122026-08-18
08057717553710BRM BIOPLAN INSTRUMENTBioplan - Trial Size 13SBPI10P0132026-08-18
08057717553727BRM BIOPLAN INSTRUMENTProbe – BioplanSBPI10S0012026-08-18
08057717553734BRM BIOPLAN INSTRUMENTGuide wire Ø 2 mm - BioplanSBPI1PG0012026-08-18
08057717553741BRM BIOPLAN INSTRUMENTPush wireSBPI1SF0012026-08-18
08057717553758BRM BIOPLAN INSTRUMENTSBioplan Sterilization TraySBPI000000B2026-08-18
08053782783755Bioplan Titanium implantBioplan Titanium implant 7DBI1070132026-08-14
08053782783762Bioplan Titanium implantBioplan Titanium implant 8DBI1080142026-08-14
08053782783779Bioplan Titanium implantBioplan Titanium implant 9DBI1090152026-08-14
08053782783786Bioplan Titanium implantBioplan Titanium implant 10DBI1100162026-08-14
08053782783793Bioplan Titanium implantBioplan Titanium implant 11DBI1110172026-08-14
08053782783809Bioplan Titanium implantBioplan Titanium implant 12DBI1120182026-08-14

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