FDA.reportPublic FDA data

INTRAFIX

Primary DI
10886705013654
Brand
INTRAFIX
Company
Medos International Sàrl
Model
254684
Catalog number
254684
Device description
FEMORAL INTRAFIX, HARD Includes (1) 9mm Sheath and (1) 8mm Screw 9mm-10mm x 23mm
Published
2015-09-01
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
HTYPIN, FIXATION, SMOOTH
HWCScrew, fixation, bone
JDRStaple, fixation, bone
MAIFastener, fixation, biodegradable, soft tissue
MBIFASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTYPin, Fixation, SmoothOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2
JDRStaple, Fixation, BoneOrthopedic2
MAIFastener, Fixation, Biodegradable, Soft TissueOrthopedic2
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063577000
K150209000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063577000FEMORAL INTRAFIX SCREW AND SHEATHJohnson & Johnson Company2007-01-25MBI
K150209000Healix BR Anchor, Healix PEEK Anchor, Healix Transtend, Gryphon T and P BR Anchor, Gryphon PEEK Anchor, VersaLok Anchor, Bioknotless BR Anchor, Lupine BR Anchor, PanaLok Anchor,PanaLok Anchor with Orthocord, PanaLok RC QuickAnchor Plus; PanaLok RC QuickAnchor Plus Dual Suture, PanaLok RC QuickAnchor Plus w/Orthocord; PanaLok RC QuickAnchor Plus Dual Suture w/Orthocord, PanaLok Loop Anchor, Lupine Loop Anchor, PanaLok RC Lop Anchor, BioKnotless Anchor, BioKnotless RC Anchor, RC Loop AncDepuy Mitek, A Johnson and Johnson Company2015-10-06MAI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886705013654PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670501365410886705013654

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable rod intended to be used for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, or used in dentistry/orthodontics, craniofacial or spinal bones. It is typically of cortical or cancellous design and has a drive (e.g., a slot, or of cross, star, or polygonal shape) at its proximal end for introduction with a screwdriver. It is made of non-bioabsorbable materials (e.g., surgical steel).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
482661753
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034647302CROSSNAV CONDUIT3010-21-9963010219962026-07-09
10705034647319CROSSNAV CONDUIT3010-21-9993010219992026-07-09
10705034647326CROSSNAV CONDUIT3010-21-3323010213322026-07-09
10705034647333CROSSNAV CONDUIT3010-21-3313010213312026-07-09
10705034647340CROSSNAV CONDUIT3010-21-2103010212102026-07-09
10705034647357CROSSNAV CONDUIT3010-21-2113010212112026-07-09
10705034647364CROSSNAV CONDUIT3010-21-2123010212122026-07-09
10705034647371CROSSNAV CONDUIT3010-21-2133010212132026-07-09
10705034647388CROSSNAV CONDUIT3010-21-2143010212142026-07-09
10705034647395CROSSNAV CONDUIT3010-21-2153010212152026-07-09
10705034647418CROSSNAV CONDUIT3010-21-2083010212082026-07-09
10705034647425CROSSNAV CONDUIT3010-21-2093010212092026-07-09
10705034647432CROSSNAV CONDUIT3010-21-3203010213202026-07-09
10705034647449CROSSNAV CONDUIT3010-21-3153010213152026-07-09
10705034647456CROSSNAV CONDUIT3010-21-9983010219982026-07-09
10705034647463N/A3010-21-3403010213402026-07-09
10705034647470CROSSNAV CONDUIT3010-21-3013010213012026-07-09
10705034647487CROSSNAV CONDUIT3010-21-3033010213032026-07-09
10705034647494CROSSNAV CONDUIT3010-21-3143010213142026-07-09
10705034647500CROSSNAV CONDUIT3010-21-3133010213132026-07-09

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