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FDA 510(k)

OXFORD ANKLE FUSION NAIL(AFN) SYSTEM

K-Number: K121575 · 2012-09-14

ApplicantOrtho Solutions Limited
Decision Date2012-09-14
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OXFORD ANKLE FUSION NAIL(AFN) SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Solutions Limited. It received FDA 510(k) clearance on 2012-09-14 under 510(k) number K121575. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OXFORD ANKLE FUSION NAIL(AFN) SYSTEM?

OXFORD ANKLE FUSION NAIL(AFN) SYSTEM is a medical device that received FDA 510(k) clearance on 2012-09-14. The listed applicant is Ortho Solutions Limited. The 510(k) number is K121575.

When did OXFORD ANKLE FUSION NAIL(AFN) SYSTEM receive FDA 510(k) clearance?

OXFORD ANKLE FUSION NAIL(AFN) SYSTEM received FDA 510(k) clearance on 2012-09-14, under 510(k) number K121575.

Who is the listed applicant for OXFORD ANKLE FUSION NAIL(AFN) SYSTEM?

The FDA 510(k) record lists Ortho Solutions Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OXFORD ANKLE FUSION NAIL(AFN) SYSTEM?

The FDA product code for OXFORD ANKLE FUSION NAIL(AFN) SYSTEM is HSB.

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Other records listing Ortho Solutions Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K120360ORTHO SOLUTIONS TRAUMA PLATES FOR OSTEOSYSNTHESISK111678ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESISK110895ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESISK102743ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES

Related Devices (Code: HSB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.K261481Pangea Femur Reconstruction SystemStryker GmbHK253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized OrthopedicsK253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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