FDA.reportPublic FDA data

EPIX Distal Screw 45.0mm x 5mm

Primary DI
B2219001045051
Brand
EPIX Distal Screw 45.0mm x 5mm
Company
Epix Orthopaedics Inc.
Model
9001-04505
Catalog number
9001-04505
Device description
Intramedullary And Accessories
Published
2019-03-05
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
HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133104000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133104000VAN HIP FRACTURE SYSTEMEpix Orthopaedic, Corp.2014-03-10HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B2219001045051PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Flexible bone nail, sterileA sterile, bending rod made of metal designed for insertion into the intramedullary canal of a long bone for fracture fixation where flexibility of the implant is desired. It is available in various lengths and diameters for use on lower and upper extremity diaphyseal fractures and some metaphyseal fractures of paediatrics and small-statured/normal adults to provide temporary stabilization of the bone segments/fragments until bone consolidation has been achieved. It is designed to splint the cortices with optimal force and maintain the elastic energy to continually brace against rotational/angular forces of the muscles. It may also reduce the fracture. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length45Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(844)710-9105epixortho@icloud.com

Regulatory Flags#

DUNS number
084913303
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B2213110205111EPIX VAN3110-205113110-205112019-03-05
B2213210205101EPIX Assy, VAN, 10mm Dia, 205mm3210-205103210-205102019-03-05
B221321028010L1EPIX Assy, Long Nail 10mm x 280mm Left3210-28010L3210-28010L2019-03-05
B221321028010R1EPIX Assy, Long Nail 10mm x 280mm Right3210-28010R3210-28010R2019-03-05
B221321030010L1EPIX Assy, Long Nail 10mm x 300mm Left3210-30010L3210-30010L2019-03-05
B221321030010R1EPIX Assy, Long Nail 10mm x 300mm Right3210-30010R3210-30010R2019-03-05
B221321032010L1EPIX Assy, Long Nail 10mm x 320mm Left3210-32010L3210-32010L2019-03-05
B221321032010R1EPIX Assy, Long Nail 10mm x 320mm Right3210-32010R3210-32010R2019-03-05
B221321034010L1EPIX Assy, Long Nail 10mm x 340mm Left3210-34010L3210-34010L2019-03-05
B221321034010R1EPIX Assy, Long Nail 10mm x 340mm Right3210-34010R3210-34010R2019-03-05
B221321036010L1EPIX Assy, Long Nail 10mm x 360mm Left3210-36010L3210-36010L2019-03-05
B221321036010R1EPIX Assy, Long Nail 10mm x 360mm Right3210-36010R3210-36010R2019-03-05
B221321038010L1EPIX Assy, Long Nail 10mm x 380mm Left3210-38010L3210-38010L2019-03-05
B221321038010R1EPIX Assy, Long Nail 10mm x 380mm Right3210-38010R3210-38010R2019-03-05
B221321040010L1EPIX Assy, Long Nail 10mm x 400mm Left3210-40010L3210-40010L2019-03-05
B221321040010R1EPIX Assy, Long Nail 10mm x 400mm Right3210-40010R3210-40010R2019-03-05
B221321042010L1EPIX Assy, Long Nail 10mm x 420mm Left3210-42010L3210-42010L2019-03-05
B221321042010R1EPIX Assy, Long Nail 10mm x 420mm Right3210-42010R3210-42010R2019-03-05
B221321044010L1EPIX Assy, Long Nail 10mm x 440mm Left3210-44010L3210-44010L2019-03-05
B221321044010R1EPIX Assy, Long Nail 10mm x 440mm Right3210-44010R3210-44010R2019-03-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B058AHN08165L1Atlas™ Humeral Nail SystemOrthopedic Designs North America, Inc.HSB2026-05-29
B058AHN08165R1Atlas™ Humeral Nail SystemOrthopedic Designs North America, Inc.HSB2026-05-29
10855068008423Lock ActivatorCURVAFIX, INC.HSB2022-06-20
10855068008492Inserter/ExtractorCURVAFIX, INC.HSB2022-06-20
10855068008539Sterilization Case, OuterCURVAFIX, INC.HSB2022-06-20
10855068008621Ring Lock, Long InserterCURVAFIX, INC.HSB2022-06-20
10855068008003CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
10855068008010CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
10855068008027CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
10855068008034CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
10855068008041CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
10855068008058CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
10855068008065CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
10855068008072CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
10855068008089CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
10855068008096CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
10855068008102CurvaFix® IM ImplantCURVAFIX, INC.HSB2021-08-11
07898624869669NEONAIL Neoortho Produtos Ortopédicos S/A.HSB2015-10-21
07898624869140NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869157NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869164NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869171NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869188NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869195NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869201NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869218NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869225NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869232NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869249NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869256NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06