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FDA 510(k)

MONOFIXATEUR

K-Number: K854336 · 1986-03-05

ApplicantOrtopedia GmbH
Decision Date1986-03-05
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MONOFIXATEUR is the device name listed in this FDA 510(k) record. The listed applicant is Ortopedia GmbH. It received FDA 510(k) clearance on 1986-03-05 under 510(k) number K854336. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONOFIXATEUR?

MONOFIXATEUR is a medical device that received FDA 510(k) clearance on 1986-03-05. The listed applicant is Ortopedia GmbH. The 510(k) number is K854336.

When did MONOFIXATEUR receive FDA 510(k) clearance?

MONOFIXATEUR received FDA 510(k) clearance on 1986-03-05, under 510(k) number K854336.

Who is the listed applicant for MONOFIXATEUR?

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

What is the FDA product code for MONOFIXATEUR?

The FDA product code for MONOFIXATEUR is HWC. This falls under the Cardiovascular category.

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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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