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FDA 510(k)

MODIFICATION TO FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM)

K-Number: K032588 · 2003-09-12

ApplicantDisco-O-Tech Medical Technologies, Ltd.
Decision Date2003-09-12
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM) is the device name listed in this FDA 510(k) record. The listed applicant is Disco-O-Tech Medical Technologies, Ltd.. It received FDA 510(k) clearance on 2003-09-12 under 510(k) number K032588. 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 MODIFICATION TO FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM)?

MODIFICATION TO FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM) is a medical device that received FDA 510(k) clearance on 2003-09-12. The listed applicant is Disco-O-Tech Medical Technologies, Ltd.. The 510(k) number is K032588.

When did MODIFICATION TO FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM) receive FDA 510(k) clearance?

MODIFICATION TO FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM) received FDA 510(k) clearance on 2003-09-12, under 510(k) number K032588.

Who is the listed applicant for MODIFICATION TO FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM)?

The FDA 510(k) record lists Disco-O-Tech Medical Technologies, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM)?

The FDA product code for MODIFICATION TO FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM) is HSB.

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Other records listing Disco-O-Tech Medical Technologies, Ltd. 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.

K031401FIXION DYNAMIC HIP SCREW SYSTEM (FIXION DHS)K023437FIXION INTERLOCKING PROXIMAL FEMUR INTRAMEDULLARY NAILING SYSTEM (FIXION PF NAILING SYSTEM), FIXION INTRAMEDULLARY NAILK021324FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAILING SYSTEM)K012967MODIFICATION TO FIXION INTERLOCKING PROXIMAL FEMORAL INTRAMEDULLARY NAILING SYSTEMK003212FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)K003215MODIFICATION OF FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)

View all 9 devices →

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

View on FDA Database →

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

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