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FDA 510(k)

METAFIX AND FIXION FA INTRAMEDULLARY NAILING SYSTEMS

K-Number: K071679 · 2007-12-17

ApplicantDisc-O-Tech Medical Technologies, Ltd.
Decision Date2007-12-17
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

METAFIX AND FIXION FA INTRAMEDULLARY NAILING SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Disc-O-Tech Medical Technologies, Ltd.. It received FDA 510(k) clearance on 2007-12-17 under 510(k) number K071679. 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 METAFIX AND FIXION FA INTRAMEDULLARY NAILING SYSTEMS?

METAFIX AND FIXION FA INTRAMEDULLARY NAILING SYSTEMS is a medical device that received FDA 510(k) clearance on 2007-12-17. The listed applicant is Disc-O-Tech Medical Technologies, Ltd.. The 510(k) number is K071679.

When did METAFIX AND FIXION FA INTRAMEDULLARY NAILING SYSTEMS receive FDA 510(k) clearance?

METAFIX AND FIXION FA INTRAMEDULLARY NAILING SYSTEMS received FDA 510(k) clearance on 2007-12-17, under 510(k) number K071679.

Who is the listed applicant for METAFIX AND FIXION FA INTRAMEDULLARY NAILING SYSTEMS?

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

What is the FDA product code for METAFIX AND FIXION FA INTRAMEDULLARY NAILING SYSTEMS?

The FDA product code for METAFIX AND FIXION FA INTRAMEDULLARY NAILING SYSTEMS is HSB.

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Related Devices (Code: HSB)

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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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