FDA.reportPublic FDA data

INTRAFIX

Primary DI
10886705013647
Brand
INTRAFIX
Company
Medos International Sàrl
Model
254683
Catalog number
254683
Device description
FEMORAL INTRAFIX, STANDARD Includes (1) 8mm Sheath and (1) 8mm Screw 8mm-8.5mm 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
OTC
false
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
10886705013647PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670501364710886705013647

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended 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, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.

Contacts#

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

Regulatory Flags#

DUNS number
482661753
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886705002085BIOKNOTLESS ORTHOCORD ETHIBOND2127222127222015-09-01
10886705002122BIOKNOTLESS ORTHOCORD ETHIBOND2127262127262015-09-01
10886705007530HEALIX PEEK ORTHOCORD2222052222052015-09-01
10886705007554HEALIX PEEK ORTHOCORD2222072222072015-09-01
10886705007578HEALIX PEEK ORTHOCORD2222092222092015-09-01
10886705007585HEALIX PEEK ORTHOCORD2222102222102015-09-01
10886705007639HEALIX PEEK ORTHOCORD2222152222152015-09-01
10886705007677HEALIX PEEK ORTHOCORD2222192222192015-09-01
10886705007691HEALIX PEEK ORTHOCORD2222212222212015-09-01
10886705007769ORTHOCORD HEALIX BR2222292222292015-09-01
10886705007783ORTHOCORD HEALIX BR2222322222322015-09-01
10886705007790ORTHOCORD HEALIX BR2222332222332015-09-01
10886705007844ORTHOCORD HEALIX BR2222382222382015-09-01
10886705007851ORTHOCORD HEALIX BR2222392222392015-09-01
10886705013616INTRAFIX2546802546802015-09-01
10886705013623INTRAFIX2546812546812015-09-01
10886705013630INTRAFIX2546822546822015-09-01
10886705013654INTRAFIX2546842546842015-09-01
10886705013661INTRAFIX2546852546852015-09-01
10886705032204PUREVUE2423292423292021-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700569633943NANEWCLIP TECHNICSHWC2026-10-01
03700569633967NANEWCLIP TECHNICSHWC2026-10-01
03700569633981NANEWCLIP TECHNICSHWC2026-10-01
03700569634001NANEWCLIP TECHNICSHWC2026-10-01
03700569634025NANEWCLIP TECHNICSHWC2026-10-01
03700569634049NANEWCLIP TECHNICSHWC2026-10-01
03700569634063NANEWCLIP TECHNICSHWC2026-10-01
00885556838211Total Foot System 2Smith & Nephew, Inc.HWC2023-04-18
09353903002468FO Micro Screw SystemFIELD ORTHOPAEDICS PTY LTDHTY2020-05-19
09353903008484FO Micro Screw SystemFIELD ORTHOPAEDICS PTY LTDHTY2019-12-13
00812926029580TigerTrilliant Surgical, LLCHWC2019-08-15
10886705001804QUICKANCHOR ETHIBONDDEPUY MITEK, LLCJDR2015-09-01
10886705002535QUICKANCHOR ETHIBONDDEPUY MITEK, LLCHWC2015-09-01
10886705002542QUICKANCHOR ETHIBONDDEPUY MITEK, LLCHWC2015-09-01
10886705013098INTRAFIXDEPUY MITEK, LLCHTY2015-09-01
10886705013098INTRAFIXDEPUY MITEK, LLCJDR2015-09-01
10886705013098INTRAFIXDEPUY MITEK, LLCMBI2015-09-01
10886705013098INTRAFIXDEPUY MITEK, LLCMAI2015-09-01
10886705013128INTRAFIXDEPUY MITEK, LLCJDR2015-09-01
10886705013128INTRAFIXDEPUY MITEK, LLCMAI2015-09-01
10886705013128INTRAFIXDEPUY MITEK, LLCHTY2015-09-01
10886705013128INTRAFIXDEPUY MITEK, LLCMBI2015-09-01
10886705022397INTRAFIXDEPUY MITEK, LLCJDR2015-09-01
10886705022397INTRAFIXDEPUY MITEK, LLCHTY2015-09-01
10886705002399QUICKANCHOR ETHIBONDDEPUY MITEK, LLCJDR2015-09-01
10886705002399QUICKANCHOR ETHIBONDDEPUY MITEK, LLCHWC2015-09-01
10886705002399QUICKANCHOR ETHIBONDDEPUY MITEK, LLCHTY2015-09-01
10886705002399QUICKANCHOR ETHIBONDDEPUY MITEK, LLCMAI2015-09-01
10886705002399QUICKANCHOR ETHIBONDDEPUY MITEK, LLCMBI2015-09-01
10886705002405QUICKANCHOR ETHIBOND TAPERCUTDEPUY MITEK, LLCMAI2015-09-01