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)

Mpact® 3D Metal Implants - DMLS Technology

K-Number: K202568 · 2021-12-20

ApplicantMedacta International S.A.
Decision Date2021-12-20
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Mpact® 3D Metal Implants - DMLS Technology is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2021-12-20 under approval number K202568. 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 Mpact® 3D Metal Implants - DMLS Technology?

Mpact® 3D Metal Implants - DMLS Technology is a medical device that received FDA 510(k) clearance on 2021-12-20. It is manufactured by Medacta International S.A.. The 510(k) number is K202568.

When was Mpact® 3D Metal Implants - DMLS Technology approved by the FDA?

Mpact® 3D Metal Implants - DMLS Technology received FDA 510(k) clearance on 2021-12-20, under approval number K202568.

What company makes Mpact® 3D Metal Implants - DMLS Technology?

Mpact® 3D Metal Implants - DMLS Technology is manufactured by Medacta International S.A..

What is the FDA product code for Mpact® 3D Metal Implants - DMLS Technology?

The FDA product code for Mpact® 3D Metal Implants - DMLS Technology is LPH.

Related Clinical Trials

NCT07595185 Effects of Accelerated rTMS on Sleep Architecture in Chronic Insomnia Disorder NOT_YET_RECRUITING NCT07551024 Evaluation of Zygomatic Implant Placement Accuracy Using Fully Metallic vs Resin-based Static Surgical Guides in Severely Atrophic Maxilla RECRUITING NCT07574164 Closed-loop TMS for Tremor RECRUITING NCT06941558 The UK ADAPTIS Study ACTIVE_NOT_RECRUITING NCT07544264 Evaluation of 5-year Survival and Clinical Outcomes in Patients Undergoing Total Knee Arthroplasty With a Polyethylene Tibial Component NOT_YET_RECRUITING NCT06187103 Evaluation of Improved Onboard Patient Imaging ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 35106697 Interpretation of regulatory factors for 3D printing at hospitals and medical centers, or at the point of care. 3D printing in medicine (2022)

Other Devices by Medacta International S.A.

K163311GMK Revision Femoral Distal Augmentation K162061M.U.S.T. Pedicle Screw System K153273MySpine Pedicle Screw Placement Guides - LP K171058Medacta Shoulder System: Threaded Glenoid Baseplate K173267MasterLoc Stem: Lateralized Plus K170690M-Vizion Femoral Revision System

View all 146 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.

↑