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)

SIGNATURE PLANNER; SIGNATURE GUIDES

K-Number: K102795 · 2011-02-02

ApplicantMaterialise NV
Decision Date2011-02-02
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SIGNATURE PLANNER; SIGNATURE GUIDES is the device name listed in this FDA 510(k) record. The listed applicant is Materialise NV. It received FDA 510(k) clearance on 2011-02-02 under 510(k) number K102795. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIGNATURE PLANNER; SIGNATURE GUIDES?

SIGNATURE PLANNER; SIGNATURE GUIDES is a medical device that received FDA 510(k) clearance on 2011-02-02. The listed applicant is Materialise NV. The 510(k) number is K102795.

When did SIGNATURE PLANNER; SIGNATURE GUIDES receive FDA 510(k) clearance?

SIGNATURE PLANNER; SIGNATURE GUIDES received FDA 510(k) clearance on 2011-02-02, under 510(k) number K102795.

Who is the listed applicant for SIGNATURE PLANNER; SIGNATURE GUIDES?

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 SIGNATURE PLANNER; SIGNATURE GUIDES?

The FDA product code for SIGNATURE PLANNER; SIGNATURE GUIDES is JWH.

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: JWH)

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.

K262057GMK ExtensionMedacta International SAK260063GSPE SpacerThe General Hospital Corporation, d/b/a MassachusettsK262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem ExtensionsB-One Ortho, Corp.K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.

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.

↑