FDA.reportPublic FDA data

BRM TOOL Titanium Screw

Primary DI
08057717550788
Brand
BRM TOOL Titanium Screw
Company
BRM EXTREMITIES SRL
Model
TOOL Ø 2.6 x 39 SHORT THREAD
Catalog number
STO126039PS
Published
2026-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
08057717550788PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08057717550788080577175507888057717550788

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

Contacts#

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

Regulatory Flags#

DUNS number
435126746
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08057717550535BRM TOOL Titanium ScrewTOOL Ø 2.6 x 10STO126010PS2026-09-30
08057717550542BRM TOOL Titanium ScrewTOOL Ø 2.6 x 11 SHORT THREADSTO126011PS2026-09-30
08057717550566BRM TOOL Titanium ScrewTOOL Ø 2.6 x 13 SHORT THREADSTO126013PS2026-09-30
08057717550580BRM TOOL Titanium ScrewTOOL Ø 2.6 x 15 SHORT THREADSTO126015PS2026-09-30
08057717550597BRM TOOL Titanium ScrewTOOL Ø 2.6 x 17 SHORT THREADSTO126017PS2026-09-30
08057717550610BRM TOOL Titanium ScrewTOOL Ø 2.6 x 21 SHORT THREADSTO126021PS2026-09-30
08057717550627BRM TOOL Titanium ScrewTOOL Ø 2.6 x 23 SHORT THREADSTO126023PS2026-09-30
08057717550641BRM TOOL Titanium ScrewTOOL Ø 2.6 x 25 SHORT THREADSTO126025PS2026-09-30
08057717550665BRM TOOL Titanium ScrewTOOL Ø 2.6 x 27 SHORT THREADSTO126027PS2026-09-30
08057717550689BRM TOOL Titanium ScrewTOOL Ø 2.6 x 29 SHORT THREADSTO126029PS2026-09-30
08057717550702BRM TOOL Titanium ScrewTOOL Ø 2.6 x 31 SHORT THREADSTO126031PS2026-09-30
08057717550726BRM TOOL Titanium ScrewTOOL Ø 2.6 x 33 SHORT THREADSTO126033PS2026-09-30
08057717550740BRM TOOL Titanium ScrewTOOL Ø 2.6 x 35 SHORT THREADSTO126035PS2026-09-30
08057717550764BRM TOOL Titanium ScrewTOOL Ø 2.6 x 37 SHORT THREADSTO126037PS2026-09-30
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700569633943NANEWCLIP TECHNICSHWC2026-10-01
03700569633967NANEWCLIP TECHNICSHWC2026-10-01
03700569633981NANEWCLIP TECHNICSHWC2026-10-01
03700569634001NANEWCLIP TECHNICSHWC2026-10-01
03700569634025NANEWCLIP TECHNICSHWC2026-10-01
03700569634049NANEWCLIP TECHNICSHWC2026-10-01
03700569634063NANEWCLIP TECHNICSHWC2026-10-01
08057717550535BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550542BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550566BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550580BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550597BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550610BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550627BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550641BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550665BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550689BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550702BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550726BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550740BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550764BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
00885556838211Total Foot System 2Smith & Nephew, Inc.HWC2023-04-18
00815432024322DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHWC2022-12-09
00815432024339DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHWC2022-12-09
00815432024353DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHWC2022-12-09
00815432024377DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHWC2022-12-09
00815432024391DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHWC2022-12-09
00815432024407DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHWC2022-12-09
00815432024421DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHWC2022-12-09
00815432024438DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHWC2022-12-09