FDA 510(k)

Latitud Hip Replacement System

K-Number: K222436 · 2023-05-09

Decision Date2023-05-09

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Latitud Hip Replacement System is a medical device manufactured by Meril Healthcare Pvt. , Ltd.. It received FDA 510(k) clearance on 2023-05-09 under approval number K222436. 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 Latitud Hip Replacement System?

Latitud Hip Replacement System is a medical device that received FDA 510(k) clearance on 2023-05-09. It is manufactured by Meril Healthcare Pvt. , Ltd.. The 510(k) number is K222436.

When was Latitud Hip Replacement System approved by the FDA?

Latitud Hip Replacement System received FDA 510(k) clearance on 2023-05-09, under approval number K222436.

What company makes Latitud Hip Replacement System?

Latitud Hip Replacement System is manufactured by Meril Healthcare Pvt. , Ltd..

What is the FDA product code for Latitud Hip Replacement System?

The FDA product code for Latitud Hip Replacement System is LPH.

Related Clinical Trials

NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT07601269 Replacement of the Native Mitral Valve Using the ReValve System RECRUITING NCT06414265 Reduction of Mitral Regurgitation With the SATURN Trans-Septal Transcatheter Mitral Valve Replacement (TMVR) System in Patients With Severe Symptomatic Mitral Regurgitation RECRUITING NCT06608823 ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™ RECRUITING NCT03242642 Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation. RECRUITING NCT07276711 CAPTURE-2: Controlled Arterial Protection to Ultimately Remove Embolic Material RECRUITING

Related PubMed Literature

PMID: 29653650 Comparison of adverse event and device problem rates for transcatheter aortic valve replacement and Mitraclip procedures as reported by the Transcatheter Valve Therapy Registry and the Food and Drug Administration postmarket surveillance data. American heart journal (2018)

Other Devices by Meril Healthcare Pvt. , Ltd.

K172936Destiknee Total Knee System K172857Latitud Hip Replacement System K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS Humerus and Olecranon Plates & MBOSS/FIXION Screws, ARMAR / ARTIS Tibia and Buttress Plates & MBOSS/FIXION Screws, ARMAR / ARTIS 2.4mm Plates & MBOSS/FIXION Screws, ARMAR/ ARTISClavical Hook Plate & MBOSS/FIXION Screws, ARMAR/ ARTIS Metaphyseal Plate & MBOSS/FIXION Screws, ARMAR / ARTISCalcaneal Plate & MBOSS/FIXION Screws K183532Latitud Hip Replacement System K212839Opulent TiNbN Coated Knee K222816Opulent TiNbN Coated Knee

View all 7 devices →

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.