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FDA 510(k)

FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IMN) MODEL B

K-Number: K010901 · 2001-06-19

ApplicantDisc-O-Tech Medical Technologies, Ltd.
Decision Date2001-06-19
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IMN) MODEL B 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 2001-06-19 under 510(k) number K010901. 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 FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IMN) MODEL B?

FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IMN) MODEL B is a medical device that received FDA 510(k) clearance on 2001-06-19. The listed applicant is Disc-O-Tech Medical Technologies, Ltd.. The 510(k) number is K010901.

When did FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IMN) MODEL B receive FDA 510(k) clearance?

FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IMN) MODEL B received FDA 510(k) clearance on 2001-06-19, under 510(k) number K010901.

Who is the listed applicant for FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IMN) MODEL B?

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 FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IMN) MODEL B?

The FDA product code for FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IMN) MODEL B 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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