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FDA 510(k)

Freedom Primary PCK

K-Number: K192148 · 2019-09-05

ApplicantMaxx Orthopedics, Inc.
Decision Date2019-09-05
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Freedom Primary PCK is a medical device manufactured by Maxx Orthopedics, Inc.. It received FDA 510(k) clearance on 2019-09-05 under approval number K192148. 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 Freedom Primary PCK?

Freedom Primary PCK is a medical device that received FDA 510(k) clearance on 2019-09-05. It is manufactured by Maxx Orthopedics, Inc.. The 510(k) number is K192148.

When was Freedom Primary PCK approved by the FDA?

Freedom Primary PCK received FDA 510(k) clearance on 2019-09-05, under approval number K192148.

What company makes Freedom Primary PCK?

Freedom Primary PCK is manufactured by Maxx Orthopedics, Inc..

What is the FDA product code for Freedom Primary PCK?

The FDA product code for Freedom Primary PCK is JWH.

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Other Devices by Maxx Orthopedics, Inc.

K180973Libertas Hip Replacement System K183684Libertas – Taper Uncemented Femoral Stem K183365Libertas Acetabular Hooded Liner K182574Freedom Ultra-Congruent CR Tibial Liner K200912Freedom(R) - TiNbN Coated Knee K192989Libertas E-XLPE Modular Liner

View all 17 devices →

Related Devices (Code: JWH)

K160515PS2 Knee SystemConsensus Orthopedics, Inc. K160771Destiknee Total Knee SystemMeril Healthcare Private Limited K160157LOSPA Modular Knee SystemCorentec Co., Ltd. K162273Materialise TKA Guide SystemMaterialise NV K162422Klassic Knee SystemTotal Joint Orthopedics, Inc. K161945EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm)Encore Medical L.P.

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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