POROUS COATED TOTAL HIP PROS. ACETABULAR COMPONENT— 510(k) K895607

Name: FDA 510(k) clearance K895607
Creator: U.S. Food and Drug Administration
Published: 1989-11-17

Substantially Equivalent for Some Indications

Exactech, Inc.

FDA 510(k) clearance K895607 for POROUS COATED TOTAL HIP PROS. ACETABULAR COMPONENT, Substantially Equivalent for Some Indications on 1989-11-17. Applicant: Exactech, Inc.. Device class: 3.

Clearance details

Applicant: Exactech, Inc.
Product code: Product code JDL
Device class: Class 3
Regulation: 21 CFR 888.3320
Advisory panel: Orthopedic
Date received: 1989-09-18
Decision date: 1989-11-17
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Gainesville, FL, US

Download summary PDF View on FDA.gov ↗

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K051995 — PROFEMUR RENAISSANCE HIP STEM2005-08-22
K051348 — CONSERVE TOTAL FEMORAL HEAD2005-08-19

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Adverse events under product code JDL

product code JDL

Injury: 285
Total: 285

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.