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FDA 510(k)

FIXION INTERLOCKING PROXIMAL FEMORAL NAILING SYSTEM

K-Number: K010988 · 2001-06-19

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

Device Summary

FIXION INTERLOCKING PROXIMAL FEMORAL NAILING SYSTEM 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 K010988. 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 INTERLOCKING PROXIMAL FEMORAL NAILING SYSTEM?

FIXION INTERLOCKING PROXIMAL FEMORAL NAILING SYSTEM 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 K010988.

When did FIXION INTERLOCKING PROXIMAL FEMORAL NAILING SYSTEM receive FDA 510(k) clearance?

FIXION INTERLOCKING PROXIMAL FEMORAL NAILING SYSTEM received FDA 510(k) clearance on 2001-06-19, under 510(k) number K010988.

Who is the listed applicant for FIXION INTERLOCKING PROXIMAL FEMORAL NAILING SYSTEM?

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 INTERLOCKING PROXIMAL FEMORAL NAILING SYSTEM?

The FDA product code for FIXION INTERLOCKING PROXIMAL FEMORAL NAILING SYSTEM is HSB.

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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.

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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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