OXFORD ANKLE FUSION NAIL(AFN) SYSTEM OS333503

GUDID 05055662928723

AFN NAIL ALIGNMENT SHAFT

ORTHO SOLUTIONS HOLDINGS LIMITED

Orthopaedic implant aiming arm

• Primary Device ID: 05055662928723
• NIH Device Record Key: 2b02adf4-b847-4791-ac7b-f3074d2bfd81
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OXFORD ANKLE FUSION NAIL(AFN) SYSTEM
• Version Model Number: OS333503
• Catalog Number: OS333503
• Company DUNS: 218648211
• Company Name: ORTHO SOLUTIONS HOLDINGS LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +441621843599
• Email: quality@orthosol.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055662928723 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121575

FDA Product Code

• HSB: Rod, Fixation, Intramedullary And Accessories

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[05055662928723]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-22
• Device Publish Date: 2017-07-21

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

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