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FDA 510(k)

CenterMed Patient Matched Assisted Surgical Planning (ASP) System

K-Number: K201353 · 2021-06-28

ApplicantCentermed, Inc.
Decision Date2021-06-28
Product CodeDZJ
Advisory CommitteeDE
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 2021-06-28 under approval number K201353. The device is classified under product code DZJ. It was reviewed by the DE 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 2021-06-28. It is manufactured by Centermed, Inc.. The 510(k) number is K201353.

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 2021-06-28, under approval number K201353.

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 DZJ.

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.

K211614CenterMed Patient Matched Assisted Surgical Planning (ASP) System

Related Devices (Code: DZJ)

K181241KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P. K172164PROPEL DevicePropel Orthodontics, LLC K182789KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P. K193499DigiGuide SystemProtomed, Inc. K192282MedCAD® AccuPlan® SystemMedcad K181813ImmersiveView Surgical Plan (IVSP®)Immersivetouch

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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