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)

EVOLUTION MP ADAPTIVE CS INSERT

K-Number: K113325 · 2011-12-09

ApplicantWrightmedicaltechnologyinc
Decision Date2011-12-09
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EVOLUTION MP ADAPTIVE CS INSERT is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2011-12-09 under 510(k) number K113325. 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 EVOLUTION MP ADAPTIVE CS INSERT?

EVOLUTION MP ADAPTIVE CS INSERT is a medical device that received FDA 510(k) clearance on 2011-12-09. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K113325.

When did EVOLUTION MP ADAPTIVE CS INSERT receive FDA 510(k) clearance?

EVOLUTION MP ADAPTIVE CS INSERT received FDA 510(k) clearance on 2011-12-09, under 510(k) number K113325.

Who is the listed applicant for EVOLUTION MP ADAPTIVE CS INSERT?

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

What is the FDA product code for EVOLUTION MP ADAPTIVE CS INSERT?

The FDA product code for EVOLUTION MP ADAPTIVE CS INSERT 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 Wrightmedicaltechnologyinc 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.

K222835Prophecy Preoperative Navigation Alignment SystemK213342PRO-DENSE LoVisc Bone Graft SubstituteK212996Sterile PHALINX Hammertoe SystemK202815PROPHECY Preoperative Navigation Alignment SystemK201259ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating SystemK200507PRO-DENSE LoVisc Bone Graft Substitute

View all 268 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.

↑