FDA 510(k)

Provident II Hip Stem

K-Number: K190276 · 2019-03-08

Decision Date2019-03-08

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Provident II Hip Stem is a medical device manufactured by Stelkast, Inc.. It received FDA 510(k) clearance on 2019-03-08 under approval number K190276. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Provident II Hip Stem?

Provident II Hip Stem is a medical device that received FDA 510(k) clearance on 2019-03-08. It is manufactured by Stelkast, Inc.. The 510(k) number is K190276.

When was Provident II Hip Stem approved by the FDA?

Provident II Hip Stem received FDA 510(k) clearance on 2019-03-08, under approval number K190276.

What company makes Provident II Hip Stem?

Provident II Hip Stem is manufactured by Stelkast, Inc..

What is the FDA product code for Provident II Hip Stem?

The FDA product code for Provident II Hip Stem is LPH.

Other Devices by Stelkast, Inc.

K162222GENflex2 Total Knee System K173875GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert

Related Devices (Code: LPH)

K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc. K161569Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex ScrewsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics K161184iNSitu Total Hip SystemTheken Companies, LLC K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC K161190G7 Dual Mobility System, Active Articulation SystemBiomet, Inc.

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.