FDA 510(k)

ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER

K-Number: K112301 · 2012-01-06

Decision Date2012-01-06

Product CodeHSX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER is the device name listed in this FDA 510(k) record. The listed applicant is Materialise NV. It received FDA 510(k) clearance on 2012-01-06 under 510(k) number K112301. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER?

ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER is a medical device that received FDA 510(k) clearance on 2012-01-06. The listed applicant is Materialise NV. The 510(k) number is K112301.

When did ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER receive FDA 510(k) clearance?

ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER received FDA 510(k) clearance on 2012-01-06, under 510(k) number K112301.

Who is the listed applicant for ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER?

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 PLANNER?

The FDA product code for ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER is HSX.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Materialise NV as applicant

K260802Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner K251964Mimics Thoracic Planner K253308Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models K253793Materialise TKA Guide System K251554Materialise TKA Guide System K243637Materialise Personalized Guides and Models for Craniomaxillofacial Surgery

View all 55 devices →

Related Devices (Code: HSX)

K261609Freedom Partial Knee SystemMaxx Orthopedics, Inc.K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus Orthopedics K251771Cambridge Partial KneeSignature Orthopaedics Pty, Ltd.K251834Persona Partial KneeZimmer Biomet K251618MOTO Partial Knee System ExtensionMedacta International S.A.K251453Arthrex iBalance Partial Knee SystemArthrex, 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.