FDA 510(k)

ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)

Numéro K : K161668 · 2016-07-15

Date de décision2016-07-15

Code produitJWH

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS) is the device name listed in this FDA 510(k) record. The listed applicant is Conformis, Inc.. It received FDA 510(k) clearance on 2016-07-15 under 510(k) number K161668. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)?

ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS) is a medical device that received FDA 510(k) clearance on 2016-07-15. The listed applicant is Conformis, Inc.. The 510(k) number is K161668.

When did ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS) receive FDA 510(k) clearance?

ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS) received FDA 510(k) clearance on 2016-07-15, under 510(k) number K161668.

Who is the listed applicant for ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)?

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

What is the FDA product code for ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)?

The FDA product code for ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS) is JWH.

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Source officielle

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