Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Zimmer Segmental System

K-Number: K192798 · 2020-12-10

ApplicantZimmer, Inc.
Decision Date2020-12-10
Product CodeKRO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Zimmer Segmental System is a medical device manufactured by Zimmer, Inc.. It received FDA 510(k) clearance on 2020-12-10 under approval number K192798. The device is classified under product code KRO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zimmer Segmental System?

Zimmer Segmental System is a medical device that received FDA 510(k) clearance on 2020-12-10. It is manufactured by Zimmer, Inc.. The 510(k) number is K192798.

When was Zimmer Segmental System approved by the FDA?

Zimmer Segmental System received FDA 510(k) clearance on 2020-12-10, under approval number K192798.

What company makes Zimmer Segmental System?

Zimmer Segmental System is manufactured by Zimmer, Inc..

What is the FDA product code for Zimmer Segmental System?

The FDA product code for Zimmer Segmental System is KRO.

Related Clinical Trials

NCT06089291 Persona IQ Cohort Study ENROLLING_BY_INVITATION NCT04984291 Zimmer Biomet Shoulder Arthroplasty PMCF RECRUITING NCT07485829 Zimmer Biomet-RibFix Titan RECRUITING NCT07530133 Clinical Trial on Safety and Efficacy of Thoracoabdominal Endoscopic Surgical System for Pediatric Surgery NOT_YET_RECRUITING NCT06388993 Marrow Cellution™ vs. Traditional BMA Harvest Project RECRUITING

Other Devices by Zimmer, Inc.

K161830Zimmer M/L Taper Hip Prosthesis K151716Cable-Ready Cable Grip System: Cable-Ready Bone Plate System K151848Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System K172767Zimmer Trabecular Metal Reverse Shoulder System, Mini Glenoid K172114Zimmer Natural Nail System K181761Zimmer Biomet Select Ceramic Heads

View all 58 devices →

Related Devices (Code: KRO)

K163311GMK Revision Femoral Distal AugmentationMedacta International S.A. K161520ELEOS Limb Salvage SystemOnkos Surgical, Inc. K152431LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coatingWaldemar Link GmbH & Co. KG K172347GMK Hinge, GMK RevisionMedacta International S.A. K190181Instruments for LINK MEGASYSTEM-C FamilyLinkBio Corp. K191779Attune Revision LPS InsertsDepuy(Ireland)

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.

↑