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)

EXETER ALL PLASTIC ACETABULAR COMPONENT

K-Number: K936132 · 1994-06-14

ApplicantHowmedica, Inc.
Decision Date1994-06-14
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EXETER ALL PLASTIC ACETABULAR COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica, Inc.. It received FDA 510(k) clearance on 1994-06-14 under 510(k) number K936132. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXETER ALL PLASTIC ACETABULAR COMPONENT?

EXETER ALL PLASTIC ACETABULAR COMPONENT is a medical device that received FDA 510(k) clearance on 1994-06-14. The listed applicant is Howmedica, Inc.. The 510(k) number is K936132.

When did EXETER ALL PLASTIC ACETABULAR COMPONENT receive FDA 510(k) clearance?

EXETER ALL PLASTIC ACETABULAR COMPONENT received FDA 510(k) clearance on 1994-06-14, under 510(k) number K936132.

Who is the listed applicant for EXETER ALL PLASTIC ACETABULAR COMPONENT?

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

What is the FDA product code for EXETER ALL PLASTIC ACETABULAR COMPONENT?

The FDA product code for EXETER ALL PLASTIC ACETABULAR COMPONENT is JDI.

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, Inc. 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.

K984251XIA SPINE SYSTEMK984202HOWMEDICA HUMERAL INTERCALARY SYSTEMK984305ZETA MULTIZONE LOCKING NAIL SYSTEMK983885BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATESK983358G/K SFN AND STN LOCKING NAILSK982463EXTRACRANIAL RADIOTHERAPY SYSTEM

View all 36 devices →

Related Devices (Code: JDI)

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.

K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.K253434OSSTM Orthopedic Salvage SystemBiomet, Inc.K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer BiometK240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip StemsSmith & Nephew, Inc.K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics

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.

↑