FDA.reportPublic FDA data

EBA2

Primary DI
08032909627448
Brand
EBA2
Company
CITIEFFE SRL
Model
Cortical screw ø5mm L50mm
Catalog number
EBA-9050
Device description
Cortical screw ø5mm L50mm.Material: titanium alloy Ti6Al4V ELI (ASTM F136).
Published
2015-10-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K131005000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131005000EBA2 FEMORAL NAILING SYSTEMCitieffe S.R.L.2013-06-25HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08032909627448PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08032909627448080329096274488032909627448

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, sterileA small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression across bone fragments.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length50Millimeter
Outer Diameter5Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Dry and clean environment and avoid damaging the packing. Room temperature.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+39051721850info@citieffe.com

Regulatory Flags#

DUNS number
431406875
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08059386748701Orthopaedic Surgical InstrumentsEntry reamer head ø8.5mm, hole ø2.7mm5112-0852026-05-27
08059386748718ORTHOPAEDIC MANUAL SURGICAL INSTRUMENTSHandle for scalpel ø7x200mm STERILE40462026-05-26
08059386748725ORTHOPAEDIC MANUAL SURGICAL INSTRUMENTSHandle for scalpel ø8x400mm STERILE40472026-05-26
08032909626380ST.A.R. 90 F4Pin and rod clamp kitF4-52202026-03-17
08059386742440Orthopaedic Manual Surgical InstrumentsSpanner 9-11mmSF10192026-03-17
08059386744369RONDO'Ruler for Rondo' screws ø3-4-5mmVP-920212026-03-17
08059386748244RONDO'Rondo' screws ø3-4-5mm instrument tray, emptyFN9101022026-03-17
08059386748251Orthopaedic Manual Surgical InstrumentsDiapason hammer gr.300382672026-03-17
08059386748237Orthopaedic Surgical InstrumentsWire tensionerSF6470P2026-03-16
08051739535730ST.A.R. 90 F4Knee fixator distractorF4-27462026-03-10
08059386748176ORTHOPAEDIC MANUAL SURGICAL INSTRUMENTSScrews ruler kit with drill bit, ø2.5x150mmDT0720342026-02-10
08059386748183ORTHOPAEDIC MANUAL SURGICAL INSTRUMENTSScrew ruler for drill bit L.150mmDT0720352026-02-10
08059386748190ORTHOPAEDIC MANUAL SURGICAL INSTRUMENTSNails ruler kit with wire ø2x600mmDT0720332026-02-10
08052990971299Orthopaedic Surgical InstrumentsQuick-connect adapter for screw ø4mmSF13042018-12-15
08052990971305Orthopaedic Surgical InstrumentsQuick-connect adapter for screw ø5mmSF13052018-12-15
08052990971312Orthopaedic Surgical InstrumentsQuick-connect adapter for screw ø6mmSF13062018-12-15
08059386742280Orthopaedic Surgical InstrumentsImpactor/extractor guideFN9000802025-11-05
08059386742518ESTREMO FIBULAR NAILEstremo Fibular Nail end cap, standardFN0000012025-12-15
08059386742525ESTREMO FIBULAR NAILEstremo Fibular Nail end cap, 2.5mmFN0000022025-12-15
08059386742532ESTREMO FIBULAR NAILEstremo Fibular Nail end cap, 5mmFN0000052025-12-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
07898624869263NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869270NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869287NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869294NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869300NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869317NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869331NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869348NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869355NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
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07898624869379NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869386NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869393NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869409NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869416NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869423NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869430NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06