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)

ACCIN TOTAL KNEE SYSTEM

K-Number: K081127 · 2008-10-17

ApplicantAccelerated Innovation, LLC
Decision Date2008-10-17
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACCIN TOTAL KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Accelerated Innovation, LLC. It received FDA 510(k) clearance on 2008-10-17 under 510(k) number K081127. 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 ACCIN TOTAL KNEE SYSTEM?

ACCIN TOTAL KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 2008-10-17. The listed applicant is Accelerated Innovation, LLC. The 510(k) number is K081127.

When did ACCIN TOTAL KNEE SYSTEM receive FDA 510(k) clearance?

ACCIN TOTAL KNEE SYSTEM received FDA 510(k) clearance on 2008-10-17, under 510(k) number K081127.

Who is the listed applicant for ACCIN TOTAL KNEE SYSTEM?

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

What is the FDA product code for ACCIN TOTAL KNEE SYSTEM?

The FDA product code for ACCIN TOTAL KNEE SYSTEM 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 Accelerated Innovation, LLC 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.

K080647ACCIN BIPOLAR HEAD SYSTEMK080539ACCIN UNIPOLAR HEAD SYSTEMK073120ACCIN PATELLOFEMORAL SYSTEMK073531ACCIN PEDICLE SCREW SYSTEMK073530ACCIN ANTERIOR CERVICAL PLATE SYSTEMK073068ACCIN HIP SYSTEM

View all 7 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.

↑