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)

GMK FULL PE TIBIAL COMPONENTS

K-Number: K131310 · 2013-08-22

ApplicantMedacta International
Decision Date2013-08-22
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GMK FULL PE TIBIAL COMPONENTS is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International. It received FDA 510(k) clearance on 2013-08-22 under 510(k) number K131310. 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 GMK FULL PE TIBIAL COMPONENTS?

GMK FULL PE TIBIAL COMPONENTS is a medical device that received FDA 510(k) clearance on 2013-08-22. The listed applicant is Medacta International. The 510(k) number is K131310.

When did GMK FULL PE TIBIAL COMPONENTS receive FDA 510(k) clearance?

GMK FULL PE TIBIAL COMPONENTS received FDA 510(k) clearance on 2013-08-22, under 510(k) number K131310.

Who is the listed applicant for GMK FULL PE TIBIAL COMPONENTS?

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

What is the FDA product code for GMK FULL PE TIBIAL COMPONENTS?

The FDA product code for GMK FULL PE TIBIAL COMPONENTS 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 Medacta International 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.

K160605MectaLIF Anterior Stand-AloneK160289MasterLoc StemK153664M.U.S.T. Pedicle Screw SystemK133630GMK SHORT STEMK132878M.U.S.T. EXTENSIONK131518MECTACER BIOLOX OPTION HEADS

View all 28 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.

↑