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FDA 510(k)

Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix

K-Number: K183163 · 2019-02-05

ApplicantMotiva USA, LLC
Decision Date2019-02-05
Product CodeMRD
DecisionSubstantially Equivalent

Device Summary

Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Motiva USA, LLC. It received FDA 510(k) clearance on 2019-02-05 under 510(k) number K183163. The device is classified under product code MRD. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix?

Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix is a medical device that received FDA 510(k) clearance on 2019-02-05. The listed applicant is Motiva USA, LLC. The 510(k) number is K183163.

When did Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix receive FDA 510(k) clearance?

Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix received FDA 510(k) clearance on 2019-02-05, under 510(k) number K183163.

Who is the listed applicant for Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix?

The FDA 510(k) record lists Motiva USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix?

The FDA product code for Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix is MRD.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06938399Motiva Implants® Post-Approval StudyRECRUITINGNCT05437757Scaffold-guided Breast SurgeryCOMPLETEDNCT06274736Safety and Performance of Motiva® SizersCOMPLETEDNCT07367698Scaffold-guided Breast Implant Revision and Primary Breast Augmentation SurgeryRECRUITINGNCT07782801Creation and Implementation a Method for Breast Reconstruction After Radical Surgery Using Decellularized Xenomatrix in Combination With Lymphovenous Anastomosis in Breast Cancer.ACTIVE_NOT_RECRUITINGNCT06420323NovoX®Cup as Primary Dressing After Breast ReductionACTIVE_NOT_RECRUITING

Other records listing Motiva USA, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P230005Prosthesis, breast, noninflatable, internal, silicone gel-filledK211676Motiva Flora SmoothSilk Tissue Expander

Related Devices (Code: MRD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243271MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel SizerMentor Worldwide, LLCK241552MENTOR™ MemoryGel™ Enhance Single Use Gel SizerMentor Worldwide, LLCK203229NATRELLE INSPIRA Single Use Sizers for Gel ImplantsAllerganK200706Sientra OPUS Silicone Gel Breast Implant SizerSientra, 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.

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