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FDA 510(k)

Zimmer Knee Joint Replacement Prostheses MR Labeling

K-Number: K173057 · 2018-03-29

ApplicantZimmer, Inc.
Decision Date2018-03-29
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Zimmer Knee Joint Replacement Prostheses MR Labeling is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 2018-03-29 under 510(k) number K173057. 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 Zimmer Knee Joint Replacement Prostheses MR Labeling?

Zimmer Knee Joint Replacement Prostheses MR Labeling is a medical device that received FDA 510(k) clearance on 2018-03-29. The listed applicant is Zimmer, Inc.. The 510(k) number is K173057.

When did Zimmer Knee Joint Replacement Prostheses MR Labeling receive FDA 510(k) clearance?

Zimmer Knee Joint Replacement Prostheses MR Labeling received FDA 510(k) clearance on 2018-03-29, under 510(k) number K173057.

Who is the listed applicant for Zimmer Knee Joint Replacement Prostheses MR Labeling?

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

What is the FDA product code for Zimmer Knee Joint Replacement Prostheses MR Labeling?

The FDA product code for Zimmer Knee Joint Replacement Prostheses MR Labeling is JWH.

Related Clinical Trials

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.

NCT03895489Effectiveness of the Journey Total Knee Arthroplasty Versus Two Standard of Care Total Knee Arthroplasty ProsthesesCOMPLETEDNCT02469662Clinical Outcomes Study of the Nexel Total ElbowRECRUITINGNCT05391828Persona MC vs PS RCT With ROSARECRUITINGNCT06089291Persona IQ Cohort StudyACTIVE_NOT_RECRUITINGNCT02440672JOURNEY™ II CR Total Knee SystemACTIVE_NOT_RECRUITINGNCT04544904The Technology, Exercise Programming, and Activity Prescription for Enhanced Mobility (TEAM) StudyCOMPLETED

Other records listing Zimmer, Inc. as applicant

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.

PMA P060037Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearingK261683Augment Off-Axis Instrument SystemK260831Z1 Hip SystemK251840Zimmer® Persona® Personalized Knee SystemK260182Avenir® Müller Stem; Avenir Complete™ Hip SystemK253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)

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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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