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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 a medical device manufactured by Centermed, Inc.. It received FDA 510(k) clearance on 2022-08-04 under approval 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. It is manufactured by Centermed, Inc.. The 510(k) number is K211614.

When was CenterMed Patient Matched Assisted Surgical Planning (ASP) System approved by the FDA?

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

What company makes CenterMed Patient Matched Assisted Surgical Planning (ASP) System?

CenterMed Patient Matched Assisted Surgical Planning (ASP) System is manufactured by Centermed, Inc..

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

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT06011187 Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery COMPLETED NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07613892 Post Operative Skin Approximation With Cyanoacrylate Based Wound Closure Adhesives COMPLETED

Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 41915013 Few FDA Approved AI/ML Orthopaedic Devices Have EU MDR Equivalents or Peer-Reviewed Validation. Clinical orthopaedics and related research (2026) PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 41734979 Strategies to Increase Patients' Adherence to Digital Therapeutics for Musculoskeletal Diseases: A Narrative Review. Yonsei medical journal (2026)

Other Devices by Centermed, Inc.

K201353CenterMed Patient Matched Assisted Surgical Planning (ASP) System

Related Devices (Code: PBF)

K163156SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase GuidesMaterialise NV K190044VSP Orthopedics System3D Systems, Inc. K192979KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P. K2122373D-Cut3D-Side S.A. K211244VSP® Orthopedics System3D Systems K211076Patient Specific Marking GuidesAdditive Orthopaedics, LLC

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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