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FDA 510(k)

MAGELLAN INTRAMEDULLARY FEMORAL NAIL SYSTEM

K-Number: K971135 · 1997-06-05

ApplicantWrightmedicaltechnologyinc
Decision Date1997-06-05
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MAGELLAN INTRAMEDULLARY FEMORAL NAIL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 1997-06-05 under 510(k) number K971135. 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 MAGELLAN INTRAMEDULLARY FEMORAL NAIL SYSTEM?

MAGELLAN INTRAMEDULLARY FEMORAL NAIL SYSTEM is a medical device that received FDA 510(k) clearance on 1997-06-05. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K971135.

When did MAGELLAN INTRAMEDULLARY FEMORAL NAIL SYSTEM receive FDA 510(k) clearance?

MAGELLAN INTRAMEDULLARY FEMORAL NAIL SYSTEM received FDA 510(k) clearance on 1997-06-05, under 510(k) number K971135.

Who is the listed applicant for MAGELLAN INTRAMEDULLARY FEMORAL NAIL SYSTEM?

The FDA 510(k) record lists Wrightmedicaltechnologyinc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAGELLAN INTRAMEDULLARY FEMORAL NAIL SYSTEM?

The FDA product code for MAGELLAN INTRAMEDULLARY FEMORAL NAIL SYSTEM is 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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