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)

EXACTECH POROUS COAT TOTAL HIP PROST FEM STEM COMP

K-Number: K901297 · 1990-05-02

ApplicantExactech, Inc.
Decision Date1990-05-02
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

EXACTECH POROUS COAT TOTAL HIP PROST FEM STEM COMP is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 1990-05-02 under 510(k) number K901297. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the EXACTECH POROUS COAT TOTAL HIP PROST FEM STEM COMP?

EXACTECH POROUS COAT TOTAL HIP PROST FEM STEM COMP is a medical device that received FDA 510(k) clearance on 1990-05-02. The listed applicant is Exactech, Inc.. The 510(k) number is K901297.

When did EXACTECH POROUS COAT TOTAL HIP PROST FEM STEM COMP receive FDA 510(k) clearance?

EXACTECH POROUS COAT TOTAL HIP PROST FEM STEM COMP received FDA 510(k) clearance on 1990-05-02, under 510(k) number K901297.

Who is the listed applicant for EXACTECH POROUS COAT TOTAL HIP PROST FEM STEM COMP?

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

What is the FDA product code for EXACTECH POROUS COAT TOTAL HIP PROST FEM STEM COMP?

The FDA product code for EXACTECH POROUS COAT TOTAL HIP PROST FEM STEM COMP 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 Exactech, 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.

K260583Equinoxe® Shoulder SystemK250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsK243448Equinoxe® Shoulder SystemK243275Equinoxe® Scapula Fracture SystemK243839Alteon® HA Femoral StemsK240393Exactech® TRULIANT® Knee System

View all 169 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.

↑