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FDA 510(k)

FIXION DYNAMIC HIP SCREW SYSTEM (FIXION DHS)

K-Number: K031401 · 2003-08-06

ApplicantDisco-O-Tech Medical Technologies, Ltd.
Decision Date2003-08-06
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FIXION DYNAMIC HIP SCREW SYSTEM (FIXION DHS) 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 2003-08-06 under 510(k) number K031401. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIXION DYNAMIC HIP SCREW SYSTEM (FIXION DHS)?

FIXION DYNAMIC HIP SCREW SYSTEM (FIXION DHS) is a medical device that received FDA 510(k) clearance on 2003-08-06. The listed applicant is Disco-O-Tech Medical Technologies, Ltd.. The 510(k) number is K031401.

When did FIXION DYNAMIC HIP SCREW SYSTEM (FIXION DHS) receive FDA 510(k) clearance?

FIXION DYNAMIC HIP SCREW SYSTEM (FIXION DHS) received FDA 510(k) clearance on 2003-08-06, under 510(k) number K031401.

Who is the listed applicant for FIXION DYNAMIC HIP SCREW SYSTEM (FIXION DHS)?

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 DYNAMIC HIP SCREW SYSTEM (FIXION DHS)?

The FDA product code for FIXION DYNAMIC HIP SCREW SYSTEM (FIXION DHS) is KTT.

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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)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: KTT)

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.

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLCK260900DYNEX® External Fixation SystemsVilex, LLCK260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean GlobalK253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.K253202Hoffmann LRF SystemStryker GmbH

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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