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FDA 510(k)

MEDACTA BONE SCREWS - EVOLIS AND VERSAFIT

K-Number: K091069 · 2009-06-01

ApplicantMedacta International S.A.
Decision Date2009-06-01
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MEDACTA BONE SCREWS - EVOLIS AND VERSAFIT is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International S.A.. It received FDA 510(k) clearance on 2009-06-01 under 510(k) number K091069. 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 MEDACTA BONE SCREWS - EVOLIS AND VERSAFIT?

MEDACTA BONE SCREWS - EVOLIS AND VERSAFIT is a medical device that received FDA 510(k) clearance on 2009-06-01. The listed applicant is Medacta International S.A.. The 510(k) number is K091069.

When did MEDACTA BONE SCREWS - EVOLIS AND VERSAFIT receive FDA 510(k) clearance?

MEDACTA BONE SCREWS - EVOLIS AND VERSAFIT received FDA 510(k) clearance on 2009-06-01, under 510(k) number K091069.

Who is the listed applicant for MEDACTA BONE SCREWS - EVOLIS AND VERSAFIT?

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

What is the FDA product code for MEDACTA BONE SCREWS - EVOLIS AND VERSAFIT?

The FDA product code for MEDACTA BONE SCREWS - EVOLIS AND VERSAFIT is HWC. This falls under the Cardiovascular category.

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Official Source

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