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FDA 510(k)

MYKNEE CUTTING BLOCKS

K-Number: K093806 · 2010-04-08

ApplicantMedacta International S.A.
Decision Date2010-04-08
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MYKNEE CUTTING BLOCKS 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 2010-04-08 under 510(k) number K093806. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MYKNEE CUTTING BLOCKS?

MYKNEE CUTTING BLOCKS is a medical device that received FDA 510(k) clearance on 2010-04-08. The listed applicant is Medacta International S.A.. The 510(k) number is K093806.

When did MYKNEE CUTTING BLOCKS receive FDA 510(k) clearance?

MYKNEE CUTTING BLOCKS received FDA 510(k) clearance on 2010-04-08, under 510(k) number K093806.

Who is the listed applicant for MYKNEE CUTTING BLOCKS?

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 MYKNEE CUTTING BLOCKS?

The FDA product code for MYKNEE CUTTING BLOCKS is JWH.

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Related Devices (Code: JWH)

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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