FDA 510(k)

POLARSTEM Calcar Reamer Guide

K-Number: K211548 · 2021-07-19

Decision Date2021-07-19

Product CodeLZO

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

POLARSTEM Calcar Reamer Guide is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2021-07-19 under approval number K211548. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLARSTEM Calcar Reamer Guide?

POLARSTEM Calcar Reamer Guide is a medical device that received FDA 510(k) clearance on 2021-07-19. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K211548.

When was POLARSTEM Calcar Reamer Guide approved by the FDA?

POLARSTEM Calcar Reamer Guide received FDA 510(k) clearance on 2021-07-19, under approval number K211548.

What company makes POLARSTEM Calcar Reamer Guide?

POLARSTEM Calcar Reamer Guide is manufactured by Smith & Nephew, Inc..

What is the FDA product code for POLARSTEM Calcar Reamer Guide?

The FDA product code for POLARSTEM Calcar Reamer Guide is LZO.

Other Devices by Smith & Nephew, Inc.

K163086VLP MINI-MOD 2.0mm Column Plates K161233OXINIUM DH Fermoral Heads K161264TRIGEN Low Profile Bone Screws K161763Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device K162078EVOS Small Fragment Plating System K160923REDAPT Anteverted Cemented Liner

View all 107 devices →

Related Devices (Code: LZO)

K160895Initia Total Hip System & BIOCERAM AZUL(R) HEADKyocera Medical Corporation K161830Zimmer M/L Taper Hip ProsthesisZimmer, Inc. K161192Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® SystemZimmer GmbH K152893Corin Optimized Positioning System (OPS)Corin USA K160289MasterLoc StemMedacta International K152903REVIVAL(TM) Modular Revision Hip StemCorin USA

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.