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)

DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION

K-Number: K980925 · 1998-12-16

ApplicantHowmedica Corp.
Decision Date1998-12-16
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1998-12-16 under 510(k) number K980925. 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 DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION?

DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION is a medical device that received FDA 510(k) clearance on 1998-12-16. The listed applicant is Howmedica Corp.. The 510(k) number is K980925.

When did DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION receive FDA 510(k) clearance?

DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION received FDA 510(k) clearance on 1998-12-16, under 510(k) number K980925.

Who is the listed applicant for DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION?

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

What is the FDA product code for DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION?

The FDA product code for DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION 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 Howmedica Corp. 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.

K983528MICRO DYNAMIC MESHK983404TYPE 3 FEMORAL COMPONENTSK980926DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATIONK980626DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATIONK980632DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATIONK983419HOFFMANN II MIAMI POST

View all 373 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.

↑