OXFORD ANKLE FUSION NAIL(AFN) SYSTEM OS333525

GUDID 05055662944785

AFN MISS 5MM CANNULATED DRILL

ORTHO SOLUTIONS HOLDINGS LIMITED

Cannulated surgical drill bit, single-use, sterile
Primary Device ID05055662944785
NIH Device Record Key84a7e30e-bb89-4afd-b95d-58227e61d389
Commercial Distribution StatusIn Commercial Distribution
Brand NameOXFORD ANKLE FUSION NAIL(AFN) SYSTEM
Version Model NumberOS333525
Catalog NumberOS333525
Company DUNS218648211
Company NameORTHO SOLUTIONS HOLDINGS LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+441621843599
Emailquality@orthosol.com
Phone+441621843599
Emailquality@orthosol.com
Phone+441621843599
Emailquality@orthosol.com
Phone+441621843599
Emailquality@orthosol.com
Phone+441621843599
Emailquality@orthosol.com
Phone+441621843599
Emailquality@orthosol.com
Phone+441621843599
Emailquality@orthosol.com
Phone+441621843599
Emailquality@orthosol.com
Phone+441621843599
Emailquality@orthosol.com
Phone+441621843599
Emailquality@orthosol.com
Phone+441621843599
Emailquality@orthosol.com
Phone+441621843599
Emailquality@orthosol.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105055662944785 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBRod, Fixation, Intramedullary And Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2018-11-22
Device Publish Date2017-09-11

On-Brand Devices [OXFORD ANKLE FUSION NAIL(AFN) SYSTEM]

05055662957013NITINOankle fusionL FLEX SHAFT ø 4.95MM HUDSON FITTING, TL/470MM
05055662947670OXBRIDGE ANKLE FUSION NAIL 12MM X 150MM (Ti6Al4V)
05055662947663OXFORD / OXBRIDGE AFN END CAP 10MM DIA 5MM LONG
05055662947656OXBRIDGE AFN END CAP
05055662944785AFN MISS 5MM CANNULATED DRILL
05055662944761OXBRIDGE AFN DISPOSABLES - DRILLS / PIN & EXCHANGE TUBE
05055662928853AFN PRE WIRE GUIDE
05055662928846OXBRIDGE AFN MISS NAIL JIG ASSEMBLY
05055662928792AFN NAIL SPANNER
05055662928785AFN LOCKING COLLAR
05055662928778AFN ALIGNMENT JIG BOLT
05055662928761AFN RETAINING CLIP
05055662928754AFN IMPACTION CAP
05055662928747AFN HEEL PLATE
05055662928730AFN COMPRESSION NUT
05055662928723AFN NAIL ALIGNMENT SHAFT
05055662928716AFN OUTRIGGER ASSEMBLY
05055662928709AFN GENERATION II INSTRUMENT CASE WITH LID
05055662928686ALIGNEMT JIG MISS 5MM DRILL GUIDE
05055662928679ALIGNMENT JIG MISS 3.2 K-WIRE GUIDE
05055662928655OXFORD/ OXBRIDGE AFN DRIVER
05055662928648OXFORD ANKLE FUSION NAIL T-HANDLE
05055662928631OXFORD ANKLE FUSION NAIL POWER ADAPTOR
05055662928594OXFORD AFN SELF RETAINING SCREWDRIVER SHANK
05055662928570OXFORD AFN DEPTH GAUGE
05055662928495OXFORD AFN TROCAR
05055662928488OXFORD ANKLE FUSION NAIL GUIDE TUBE
05055662928471OXFORD AFN 4mm DRILL GUIDE
05055662928464OXFORD ANKLE FUSION NAIL PRIMARY JIG ASSEMBLY
05055662917802OXFORD ANKLE FUSION NAIL 12MM X 180MM (Ti6Al4V)
05055662917796OXBRIDGE ANKLE FUSION NAIL 12MM X 180MM (Ti6Al4V)
05055662917772OXFORD ANKLE FUSION NAIL 12MM X 150MM (Ti6Al4V)
05055662917758OXFORD ANKLE FUSION NAIL 10MM X 180MM (Ti6Al4V)
05055662917741OXBRIDGE ANKLE FUSION NAIL 10MM X 180MM (Ti6Al4V)
05055662917727OXBRIDGE ANKLE FUSION NAIL 10MM X 150MM (Ti6Al4V)
05055662917710OXFORD ANKLE FUSION NAIL 10MM X 150MM (Ti6Al4V)
05055662917697OXFORD ANKLE FUSION NAIL 11MM X 180MM (Ti6Al4V)
05055662917680OXBRIDGE ANKLE FUSION NAIL 11MM X 180MM (Ti6Al4V)
05055662917666OXFORD ANKLE FUSION NAIL 11MM X 150MM (Ti6Al4V)
05055662917659OXBRIDGE ANKLE FUSION NAIL 11MM X 150MM (Ti6Al4V)
05055662917468OXFORD / OXBRIDGE AFN END CAP LOCKING
05055662917451OXFORD / OXBRIDGE AFN END CAP 12MM DIA 10MM LONG
05055662917444OXFORD / OXBRIDGE AFN END CAP 12MM DIA 5MM LONG
05055662917437OXFORD / OXBRIDGE AFN END CAP 11MM DIA 10MM LONG
05055662917420OXFORD / OXBRIDGE AFN END CAP 11MM DIA 5MM LONG
05055662917413OXFORD / OXBRIDGE AFN END CAP 10MM DIA 10MM LONG
05055662914672OXFORD ANKLE FUSION NAIL X-RAY TEMPLATE, NEW NAIL
05055662910001OXBRIDGE AFN 5.0MM X 120MM CORTICAL SCREW (Ti6Al4V)
05055662909999OXBRIDGE AFN 5.0MM X 115MM CORTICAL SCREW (Ti6Al4V)
05055662909982OXBRIDGE AFN 5.0MM X 110MM CORTICAL SCREW (Ti6Al4V)
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