FDA.reportPublic FDA data

Flow-Screw™

Primary DI
B267102230
Brand
Flow-Screw™
Company
Flow-FX
Model
102-23
Catalog number
102-23
Device description
FS Washer Sheath Handle
Published
2020-12-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FZXGuide, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

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
B267102230PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.

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
B2675510700Flow-Screw™55-107055-10702024-07-22
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776423896MillenniumAvalign Technologies, Inc.FZX2026-08-26
10886982362988NASynthes GmbHFZX2026-08-26
10886982362995NASynthes GmbHFZX2026-08-26
10886982363008NASynthes GmbHFZX2026-08-26
10886982363015NASynthes GmbHFZX2026-08-26
008890247114712.9 JuggerKnot Self-Punching ObturatorZimmer, Inc.FZX2026-08-25
008890247114882.9 JuggerKnot Self-Punching CannulaZimmer, Inc.FZX2026-08-25
00889024712294Pin Target AssemblyZimmer, Inc.FZX2026-08-25
06937278653598CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
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