FDA.reportPublic FDA data

BRM TOOL PRO Titanium Screw

Primary DI
08057717555691
Brand
BRM TOOL PRO Titanium Screw
Company
BRM EXTREMITIES SRL
Model
TOOL PRO Ø 5.6 x 80 FULL THREAD
Catalog number
SOS156080TS
Published
2025-10-09
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
K222820000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222820000BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities2022-12-16HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08057717555691PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08057717555691080577175556918057717555691

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
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
08053782783724BRM TOOL VIP SCREWS INSTRUMENTCannulated extra-long Drill Bit Ø 2.0 mmSTVI224XXLP2026-04-29
08053782783656BRM INSTRUMENTQuick Coupling Silicone HandleUAOI0SA00S2026-03-24
08053782783663BRM INSTRUMENTQuick Coupling Silicone Handle PROUAOI0SA00L2026-03-24
08053782783670BRM INSTRUMENTJ-Type Quick Coupling Silicone HandleUAOI0SJ0002026-03-24
08053782783687BRM INSTRUMENTQuick Coupling Silicone Handle with ratchetUAOI0SAC0S2026-03-24
08053782783694BRM INSTRUMENTQuick Coupling Silicone Handle PRO with ratchetUAOI0SAC0L2026-03-24
08053782783700BRM INSTRUMENTJ-Type Quick Coupling Silicone Handle with ratchetUAOI0SJC002026-03-24
08053782783748TOOL VIP XL Instruments KitInstruments kit for the implant of BRM ExtremitiesKIT.TOOLVIP-012026-03-24
08053782783731BRM TOOL VIP SCREWS INSTRUMENTCannulated extra-long Drill Bit Ø 2.9mmSTVI234XXLP2026-02-19
08053782781720BRM TOOL PRO Instruments KitInstruments KitKIT.TOOLPRO-002025-07-15
08053782780082BRM TOOL PRO SCREWS INSTRUMENTLong cannulated Screwdriver BTX20STAI100020L2025-10-15
08053782780099BRM TOOL PRO SCREWS INSTRUMENTLong solid Screwdriver BTX20STAI100020PL2025-10-15
08053782780105BRM TOOL SCREWS INSTRUMENTLong cannulated Screwdriver BTX25STOI100025L2025-10-15
08053782780112BRM TOOL SCREWS INSTRUMENTLong solid Screwdriver BTX25STOI100025PL2025-10-15
08053782780372BRM INSTRUMENTJ-Type Quick Coupling HandleUAOI0MJ1002025-10-15
08053782780389BRM TOOL PRO SCREWS INSTRUMENTMetallic sterilization tray for instruments – TOOLSTOI056070BPL2025-10-15
08053782780396BRM TOOL PRO SCREWS INSTRUMENTGuidewire Ø 1.6STAIGW0162025-10-15
08053782780402BRM TOOL PRO SCREWS INSTRUMENTGuidedrill Ø 3.9STAIGD0392025-10-15
08053782780419BRM TOOL PRO SCREWS INSTRUMENTTissue protection Sleeve Ø 5.6STAIPS0562025-10-15
08053782780426BRM TOOL PRO SCREWS INSTRUMENTGuidewire Ø 2.5STAIGW0252025-10-15

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