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FDA 510(k)

MyKnee PPS-Pin Positioners

K-Number: K170106 · 2017-10-20

ApplicantMedacta International S.A.
Decision Date2017-10-20
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MyKnee PPS-Pin Positioners 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 2017-10-20 under 510(k) number K170106. 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 PPS-Pin Positioners?

MyKnee PPS-Pin Positioners is a medical device that received FDA 510(k) clearance on 2017-10-20. The listed applicant is Medacta International S.A.. The 510(k) number is K170106.

When did MyKnee PPS-Pin Positioners receive FDA 510(k) clearance?

MyKnee PPS-Pin Positioners received FDA 510(k) clearance on 2017-10-20, under 510(k) number K170106.

Who is the listed applicant for MyKnee PPS-Pin Positioners?

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 PPS-Pin Positioners?

The FDA product code for MyKnee PPS-Pin Positioners 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.

K261563Freedom Total Knee System (E-Poly Tibial Liners)Maxx Orthopedics, Inc.K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UCK261032NovoKnee (SteriKnee)NovoSourceK253793Materialise TKA Guide SystemMaterialise NV

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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