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)

LOSPA TIBIAL BASE PLATE

K-Number: K121037 · 2012-05-03

ApplicantCorentec Co., Ltd.
Decision Date2012-05-03
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LOSPA TIBIAL BASE PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Corentec Co., Ltd.. It received FDA 510(k) clearance on 2012-05-03 under 510(k) number K121037. 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 LOSPA TIBIAL BASE PLATE?

LOSPA TIBIAL BASE PLATE is a medical device that received FDA 510(k) clearance on 2012-05-03. The listed applicant is Corentec Co., Ltd.. The 510(k) number is K121037.

When did LOSPA TIBIAL BASE PLATE receive FDA 510(k) clearance?

LOSPA TIBIAL BASE PLATE received FDA 510(k) clearance on 2012-05-03, under 510(k) number K121037.

Who is the listed applicant for LOSPA TIBIAL BASE PLATE?

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

What is the FDA product code for LOSPA TIBIAL BASE PLATE?

The FDA product code for LOSPA TIBIAL BASE PLATE 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 Corentec Co., Ltd. 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.

K250889EXULT Knee Replacement SystemK242401EXULT Knee Replacement SystemK242046EXULT Knee Replacement SystemK223828BENCOX Delta Option HeadsK223223BENCOX Mirabo Z Cup CortiniumK222278LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation

View all 31 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.

↑