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FDA 510(k)

OLECRA INTRAMEDULLARY FIXATION SYSTEM

K-Number: K110322 · 2011-03-04

ApplicantMylad Orthopedic Solutions
Decision Date2011-03-04
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OLECRA INTRAMEDULLARY FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Mylad Orthopedic Solutions. It received FDA 510(k) clearance on 2011-03-04 under 510(k) number K110322. 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 OLECRA INTRAMEDULLARY FIXATION SYSTEM?

OLECRA INTRAMEDULLARY FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2011-03-04. The listed applicant is Mylad Orthopedic Solutions. The 510(k) number is K110322.

When did OLECRA INTRAMEDULLARY FIXATION SYSTEM receive FDA 510(k) clearance?

OLECRA INTRAMEDULLARY FIXATION SYSTEM received FDA 510(k) clearance on 2011-03-04, under 510(k) number K110322.

Who is the listed applicant for OLECRA INTRAMEDULLARY FIXATION SYSTEM?

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

What is the FDA product code for OLECRA INTRAMEDULLARY FIXATION SYSTEM?

The FDA product code for OLECRA INTRAMEDULLARY FIXATION SYSTEM is HSB.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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