Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, VERSION 2.0

K-Number: K093533 · 2010-02-17

ApplicantMaterialise NV
Decision Date2010-02-17
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, VERSION 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Materialise NV. It received FDA 510(k) clearance on 2010-02-17 under 510(k) number K093533. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, VERSION 2.0?

ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, VERSION 2.0 is a medical device that received FDA 510(k) clearance on 2010-02-17. The listed applicant is Materialise NV. The 510(k) number is K093533.

When did ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, VERSION 2.0 receive FDA 510(k) clearance?

ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, VERSION 2.0 received FDA 510(k) clearance on 2010-02-17, under 510(k) number K093533.

Who is the listed applicant for ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, VERSION 2.0?

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

What is the FDA product code for ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, VERSION 2.0?

The FDA product code for ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, VERSION 2.0 is MBH.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Materialise NV 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.

K260802Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerK251964Mimics Thoracic PlannerK253308Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic ModelsK253793Materialise TKA Guide SystemK251554Materialise TKA Guide SystemK243637Materialise Personalized Guides and Models for Craniomaxillofacial Surgery

View all 55 devices →

Related Devices (Code: MBH)

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.

K261275Unity Total Knee System, Unity Knee Cementless CR FemurCorin, Ltd.K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.

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.

↑