FDA.reportPublic FDA data

Flow-Nail™

Primary DI
B267101110
Brand
Flow-Nail™
Company
Flow-FX
Model
101-11
Catalog number
101-11
Device description
FN Jig Cartridge
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
NDHNail, Fixation, Bone, Metallic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDHNail, Fixation, Bone, MetallicOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140601000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140601000FLOW-NAILFlow-Fx, LLC2014-07-02HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B267101110PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant aiming/guiding block, reusableA surgical, jig-like device designed as a preshaped block with a defined pattern of prefabricated holes used to guide other instruments [e.g., drill sleeves and guide wires (Kirschner wires)] and/or to align a corresponding implant (e.g., a fixation plate) during an orthopaedic procedure. It is typically made of metallic or synthetic materials and may have an attachment point for an implant. 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B267101010Flow-Nail™ Flow-FXNDH2020-12-18
B267101100Flow-Nail™ Flow-FXNDH2020-12-18
B267101120Flow-Screw™Flow-FXNDH2020-12-18
B267101270Flow-Nail™ Flow-FXNDH2020-12-18
B267101410Flow-Nail™ Flow-FXNDH2020-12-18
B267101540Flow-Nail™ Flow-FXNDH2020-12-18
00887868089916DYNAFIX VS OSTEOTOMY SYSTEMBiomet Orthopedics, LLCNDH2015-10-24
00887868090011DYNAFIX VS OSTEOTOMY SYSTEMBiomet Orthopedics, LLCNDH2015-10-24
00887868090035DYNAFIX VS OSTEOTOMY SYSTEMBiomet Orthopedics, LLCNDH2015-10-24
00887868090042DYNAFIX VS OSTEOTOMY SYSTEMBiomet Orthopedics, LLCNDH2015-10-24
00887868090059DYNAFIX VS OSTEOTOMY SYSTEMBiomet Orthopedics, LLCNDH2015-10-24
00887868090066DYNAFIX VS OSTEOTOMY SYSTEMBiomet Orthopedics, LLCNDH2015-10-24
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00887868090097DYNAFIX VS OSTEOTOMY SYSTEMBiomet Orthopedics, LLCNDH2015-10-24
00887868090103DYNAFIX VS OSTEOTOMY SYSTEMBiomet Orthopedics, LLCNDH2015-10-24
00887868090110DYNAFIX VS OSTEOTOMY SYSTEMBiomet Orthopedics, LLCNDH2015-10-24
00887868090127DYNAFIX VS OSTEOTOMY SYSTEMBiomet Orthopedics, LLCNDH2015-10-24
00887868090134DYNAFIX VS OSTEOTOMY SYSTEMBiomet Orthopedics, LLCNDH2015-10-24
00887868090141DYNAFIX VS OSTEOTOMY SYSTEMBiomet Orthopedics, LLCNDH2015-10-24
00887868090158DYNAFIX VS OSTEOTOMY SYSTEMBiomet Orthopedics, LLCNDH2015-10-24
00887868090165DYNAFIX VS OSTEOTOMY SYSTEMBiomet Orthopedics, LLCNDH2015-10-24
00887868090172DYNAFIX VS OSTEOTOMY SYSTEMBiomet Orthopedics, LLCNDH2015-10-24
00887868090196DYNAFIX VS OSTEOTOMY SYSTEMBiomet Orthopedics, LLCNDH2015-10-24
00887868090202VS OSTEOTOMY SYSTEMBiomet Orthopedics, LLCNDH2015-10-24
00887868151378DYNAFIX VS OSTEOTOMY SYSTEMBiomet Orthopedics, LLCNDH2015-10-24
00888480153450DYNAFIX VS OSTEOTOMY SYSTEMBiomet Orthopedics, LLCNDH2015-10-24
00888480153498DYNAFIX VS OSTEOTOMY SYSTEMBiomet Orthopedics, LLCNDH2015-10-24
00888480153511DYNAFIX VS OSTEOTOMY SYSTEMBiomet Orthopedics, LLCNDH2015-10-24
00888480187776DYNAFIX VS OSTEOTOMY SYSTEMBiomet Orthopedics, LLCNDH2015-10-24