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FDA 510(k)

FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)

K-Number: K003212 · 2000-12-28

ApplicantDisco-O-Tech Medical Technologies, Ltd.
Decision Date2000-12-28
Product CodeJDS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL) 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 2000-12-28 under 510(k) number K003212. The device is classified under product code JDS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)?

FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL) is a medical device that received FDA 510(k) clearance on 2000-12-28. The listed applicant is Disco-O-Tech Medical Technologies, Ltd.. The 510(k) number is K003212.

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

FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL) received FDA 510(k) clearance on 2000-12-28, under 510(k) number K003212.

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

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 FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)?

The FDA product code for FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL) is JDS.

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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.

K032588MODIFICATION TO FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM)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 SYSTEMK003215MODIFICATION OF FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)

View all 9 devices →

Related Devices (Code: JDS)

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.

K243608TRIGEN Stable Lock Nut & WasherSmith & Nephew, Inc.K240061TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail SystemSmith & Nephew, Inc.K241804TRIGEN INTERTAN 10S Nail SystemSmith & Nephew, Inc.K233150NET BRAND Osteosynthesis Nailing SystemNarang Medical , Ltd.K230761TRIGEN META-NAIL Nail SystemSmith & Nephew, Inc.K201336DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mmSynthes (USA) Products, LLC

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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