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FDA 510(k)

CenterMed Patient Matched Assisted Surgical Planning (ASP) System

K-Number: K211614 · 2022-08-04

ApplicantCentermed, Inc.
Decision Date2022-08-04
Product CodePBF
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CenterMed Patient Matched Assisted Surgical Planning (ASP) System is the device name listed in this FDA 510(k) record. The listed applicant is Centermed, Inc.. It received FDA 510(k) clearance on 2022-08-04 under 510(k) number K211614. The device is classified under product code PBF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CenterMed Patient Matched Assisted Surgical Planning (ASP) System?

CenterMed Patient Matched Assisted Surgical Planning (ASP) System is a medical device that received FDA 510(k) clearance on 2022-08-04. The listed applicant is Centermed, Inc.. The 510(k) number is K211614.

When did CenterMed Patient Matched Assisted Surgical Planning (ASP) System receive FDA 510(k) clearance?

CenterMed Patient Matched Assisted Surgical Planning (ASP) System received FDA 510(k) clearance on 2022-08-04, under 510(k) number K211614.

Who is the listed applicant for CenterMed Patient Matched Assisted Surgical Planning (ASP) System?

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

What is the FDA product code for CenterMed Patient Matched Assisted Surgical Planning (ASP) System?

The FDA product code for CenterMed Patient Matched Assisted Surgical Planning (ASP) System is PBF.

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.

NCT07593872XR-Assisted PET/CT Navigation for Cervical Lymph Node Dissection in Lung CancerNOT_YET_RECRUITING

Other records listing Centermed, Inc. 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.

K201353CenterMed Patient Matched Assisted Surgical Planning (ASP) System

Related Devices (Code: PBF)

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.

K252064MedCAD® AccuStride™ SystemMedcadK250711VSP Orthopedics System3D Systems, Inc.K242603MyPAO SA guidesMedacta International S.A.K251709MedCAD® AccuStride™ SystemMedcadK250394Fine TTO™Bodycad Laboratories, Inc.K250767Newclip Patient-matched instrumentation non sterile PSINewclip Technics

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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