FDA.reportPublic FDA data

Flow-Screw™

Primary DI
B2671025101D0
Brand
Flow-Screw™
Company
Flow-FX
Model
102-51-01D
Catalog number
102-51-01D
Device description
Plunger, 5.5 mm Screw
Published
2022-02-08
Public version status
New
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
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

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
B2671025101D0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic coaxial injection applicatorA tubular device with a concentric dual-lumen and a plunger intended to be used during surgery for the percutaneous injection of therapeutic materials (e.g., biologics, bone void fillers, irrigation fluids) into a bone, having been passed over a guidewire to the injection site. Typically, the inner lumen is used for the guidewire and the outer lumen for injection of fluids aided by the plunger. The device is made of metal and/or polymer materials. This is a single-use 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630894827723AVENGERMedartis AGLXH2026-10-13
07630894827730AVENGERMedartis AGLXH2026-10-13
07630894827747AVENGERMedartis AGLXH2026-10-13
00190776434762MillenniumAvalign Technologies, Inc.LXH2026-10-12
00850080243176OSTEOROD Delivery SystemBONE SOLUTIONS, INC.LXH2026-10-12
00889795150264APEX 3D Total Ankle Replacement SystemParagon 28, Inc.LXH2026-10-12
00724995225148NASTERIS CORPORATIONLXH2025-03-31
00196449010219A.L.P.S. mvX™Tyber Medical, LLCLXH2023-12-15
00196449012800A.L.P.S. mvX™Tyber Medical, LLCLXH2023-12-15
B0842002000400Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000410Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000420Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000430Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000440Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000450Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000460Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000470Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000480Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000490Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000500Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000600Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000610Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000620Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000630Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000640Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000650Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000660Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000670Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000680Keos Lumbar InstrumentKEOSLXH2023-02-07
B0842002000690Keos Lumbar InstrumentKEOSLXH2023-02-07