101-32 FEMORAL COMPONENT— 510(k) K813599

Name: FDA 510(k) clearance K813599
Creator: U.S. Food and Drug Administration
Published: 1982-01-22

Substantially Equivalent

Intermedics Orthopedics

FDA 510(k) clearance K813599 for 101-32 FEMORAL COMPONENT, Substantially Equivalent on 1982-01-22. Applicant: Intermedics Orthopedics. Device class: 3.

Clearance details

Applicant: Intermedics Orthopedics
Product code: Code JDL
Device class: Class 3
Regulation: 21 CFR 888.3320
Advisory panel: Orthopedic
Date received: 1981-12-28
Decision date: 1982-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JDL

view all

K073499 — VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES2008-08-07
K070785 — DYNASTY ACETABULAR SYSTEM2007-07-11
K061844 — DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINER2006-12-06
K051995 — PROFEMUR RENAISSANCE HIP STEM2005-08-22
K051348 — CONSERVE TOTAL FEMORAL HEAD2005-08-19

More clearances from Intermedics Orthopedics

view all

K970300 — NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTI1997-07-03
K970498 — NATURAL-KNEE II REVISION FEMORAL SPACER LUGS1997-04-30
K970166 — NATURAL-HIP SYSTEM COCR REVISION STEM1997-04-08
K970567 — SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS1997-02-27
K964357 — NATURAL-HIP SYSTEM COCR STEM1997-01-27

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.