FDA.reportPublic FDA data

Flow-Screw™

Primary DI
B2675510700
Brand
Flow-Screw™
Company
Flow-FX
Model
55-1070
Catalog number
55-1070
Device description
5.5/70mm Flow-Screw Partial Thread Long
Published
2024-07-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
K142776000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142776000Flow-ScrewFlow-Fx, LLC2015-03-23HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B2675510700PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended to be used 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, or used in dentistry/orthodontics, craniofacial or spinal bones. It is typically of cortical or cancellous design and has a drive (e.g., a slot, or of cross, star, or polygonal shape) at its proximal end for introduction with a screwdriver. It is made of non-bioabsorbable materials (e.g., metal).

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
079293587
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B2672CAN35002-CAN™2CAN3502CAN3502025-07-11
B267101120Flow-Screw™101-12101-122020-12-18
B267101270Flow-Nail™ 101-27101-272020-12-18
B267101410Flow-Nail™ 101-41101-412020-12-18
B267101540Flow-Nail™ 101-54101-542020-12-18
B26710218000Flow-Screw™102-18-00102-18-002020-12-18
B26710218010Flow-Screw™102-18-01102-18-012020-12-18
B26710218100Flow-Screw™102-18-10102-18-102020-12-18
B26710218110Flow-Screw™102-18-11102-18-112020-12-18
B26710218200Flow-Screw™102-18-20102-18-202020-12-18
B26710218210Flow-Screw™102-18-21102-18-212020-12-18
B2675520750Flow-Screw™55-207555-20752024-07-22
B2675510600Flow-Screw™55-106055-10602018-06-22
B2675510650Flow-Screw™55-106555-10652018-06-22
B2675520650Flow-Screw™55-206555-20652018-06-22
B267A600Flow-Nail™A60A602018-06-21
B267C400Flow-Nail™C40C402018-06-22
B267101290Flow-Nail™ 101-29101-292022-02-08
B26710230050Flow-Screw™102-30-05102-30-052024-08-29
B26710240000Flow-Screw™102-40-00102-40-002020-12-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08057717550788BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550009BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550016BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550023BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550030BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550047BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550061BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550290BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550313BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550368BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550382BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550405BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550429BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550443BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550467BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09
08057717550481BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2025-07-09