FDA.reportPublic FDA data

INTRAFIX

Primary DI
10886705022397
Brand
INTRAFIX
Company
DEPUY MITEK, LLC
Model
254653
Catalog number
254653
Device description
INTRAFIX PEEK Tapered Screw 7-9mm x 30mm
Published
2015-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTYPIN, FIXATION, SMOOTH
JDRStaple, fixation, bone
MAIFastener, fixation, biodegradable, soft tissue
MBIFASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K013572000
K122123000
K150209000
K983560000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013572000MITEK BIOCRYL INTERFERENCE SCREWSMitek Products2002-03-14HWC
K1221230006-8MM X 30 MM INTRAFIX PEEK TAPERED SCREW 7-9MM X 30MM INTRAFIX PEEK TAPERED SCREW 8-10MM X 30 MM INTRAFIX PEEK TAPEREDDepuy Mitek, Inc., A Johnson and Johnson Company2012-10-02MBI
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
K983560000INNOVASIVE DEVICES INTRATUNNEL TIBIAL FIXATION FASTENERInnovasive Devices, Inc.1999-01-28MBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886705022397PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670502239710886705022397

GMDN Terms#

Term, Definition table
TermDefinition
Tendon/ligament bone anchor, non-bioabsorbableA non-bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)].

Contacts#

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

Regulatory Flags#

DUNS number
190572854
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
10886705001804QUICKANCHOR ETHIBOND2120322120322015-09-01
10886705002535QUICKANCHOR ETHIBOND2128662128662015-09-01
10886705002542QUICKANCHOR ETHIBOND2128672128672015-09-01
10886705003747NA2145282145282015-09-01
10886705006892NA2198132198132017-03-17
10886705006908NA2198142198142017-03-17
10886705006922NA2198162198162017-03-17
10886705013098INTRAFIX2546032546032015-09-01
10886705013104NA2546042546042015-09-01
10886705013128INTRAFIX2546092546092015-09-01
10886705013531INTRAFIX2546712546712015-09-01
10886705020607FMS DUO2845802845802015-09-01
10886705020614FMS SOLO2845902845902015-09-01
10886705023431HEALIX ADVANCE2223352223352015-09-01
10886705023455HEALIX ADVANCE2223332223332015-09-01
10886705023486HEALIX ADVANCE2223342223342015-09-01
10886705002399QUICKANCHOR ETHIBOND2128502128502015-09-01
10886705002405QUICKANCHOR ETHIBOND TAPERCUT2128512128512015-09-01
10886705002443MICROFIX QUICKANCHOR ETHIBOND2128552128552015-09-01
10886705002450MICROFIX QUICKANCHOR ETHIBOND2128562128562015-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09353903002468FO Micro Screw SystemFIELD ORTHOPAEDICS PTY LTDHTY2020-05-19
09353903008484FO Micro Screw SystemFIELD ORTHOPAEDICS PTY LTDHTY2019-12-13
10886705030835HEALIX ADVANCE DYNA+TAPE PERMATAPE DYNACORDMedos International SàrlMAI2019-07-11
10886705030842HEALIX ADVANCE DYNA+TAPE PERMATAPE DYNACORDMedos International SàrlMAI2019-07-11
10886705030859HEALIX ADVANCE DYNA+TAPE PERMATAPE DYNACORDMedos International SàrlMAI2019-07-11
10886705030866HEALIX ADVANCE DYNA+TAPE PERMATAPE DYNACORDMedos International SàrlMAI2019-07-11
10886705030873HEALIX ADVANCE DYNA+TAPE PERMATAPE DYNACORDMedos International SàrlMAI2019-07-11
10886705030880HEALIX ADVANCE DYNA+TAPE PERMATAPE DYNACORDMedos International SàrlMAI2019-07-11
10886705030897HEALIX ADVANCE DYNA+TAPE PERMATAPE DYNACORDMedos International SàrlMBI2019-07-11
10886705030903HEALIX ADVANCE DYNA+TAPE PERMATAPE DYNACORDMedos International SàrlMBI2019-07-11
10886705030910HEALIX ADVANCE DYNA+TAPE PERMATAPE DYNACORDMedos International SàrlMBI2019-07-11
10886705030927HEALIX ADVANCE DYNA+TAPE PERMATAPE DYNACORDMedos International SàrlMBI2019-07-11
10886705030934HEALIX ADVANCE DYNA+TAPE PERMATAPE DYNACORDMedos International SàrlMBI2019-07-11
10886705030941HEALIX ADVANCE DYNA+TAPE PERMATAPE DYNACORDMedos International SàrlMBI2019-07-11
00815432023288DynaFORCE™CROSSROADS EXTREMITY SYSTEMSJDR2017-03-21
00815432023301DynaFORCE™CROSSROADS EXTREMITY SYSTEMSJDR2017-03-21
00815432023318DynaFORCE™CROSSROADS EXTREMITY SYSTEMSJDR2017-03-21
00815432023325DynaFORCE™CROSSROADS EXTREMITY SYSTEMSJDR2017-03-21
00815432023332DynaFORCE™CROSSROADS EXTREMITY SYSTEMSJDR2017-03-21
00815432023356DynaFORCE™CROSSROADS EXTREMITY SYSTEMSJDR2017-03-21
00815432023363DynaFORCE™CROSSROADS EXTREMITY SYSTEMSJDR2017-03-21
00815432022830MotoBANDCROSSROADS EXTREMITY SYSTEMSJDR2016-04-26
00815432022847MotoBANDCROSSROADS EXTREMITY SYSTEMSJDR2016-04-26
00815432022854MotoBANDCROSSROADS EXTREMITY SYSTEMSJDR2016-04-26
00815432022861MotoBANDCROSSROADS EXTREMITY SYSTEMSJDR2016-04-26
00815432022878MotoBANDCROSSROADS EXTREMITY SYSTEMSJDR2016-04-26
00815432022885MotoBANDCROSSROADS EXTREMITY SYSTEMSJDR2016-04-26
00815432022892MotoBANDCROSSROADS EXTREMITY SYSTEMSJDR2016-04-26
00815432022908MotoBANDCROSSROADS EXTREMITY SYSTEMSJDR2016-04-26
00815432022915MotoBANDCROSSROADS EXTREMITY SYSTEMSJDR2016-04-26