SPHERISTEM TOTAL HIP PROSTHESIS— 510(k) K780497

Name: FDA 510(k) clearance K780497
Creator: U.S. Food and Drug Administration
Published: 1978-06-14

Substantially Equivalent

American Ortomed Corp.

FDA 510(k) clearance K780497 for SPHERISTEM TOTAL HIP PROSTHESIS, Substantially Equivalent on 1978-06-14. Applicant: American Ortomed Corp.. Device class: 2.

Clearance details

Applicant: American Ortomed Corp.
Product code: Code JDG
Device class: Class 2
Regulation: 21 CFR 888.3360
Advisory panel: Orthopedic
Date received: 1978-03-28
Decision date: 1978-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JDG

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K173499 — Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads2018-03-19
K001984 — PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT2000-09-27
K992234 — THE TAPER-FIT TOTAL HIP SYSTEM1999-11-10

More clearances from American Ortomed Corp.

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K842466 — TITANIUM MITTELMEIER TYPE ACETABULAR1985-01-30
K842518 — UNILOC-CEMENTLESS & SELF TAP ACETABULAR1985-01-30
K842465 — UNILOC1984-11-19
K840413 — CEMENT RESTRICTOR1984-03-05
K820719 — THE ICR KNEE1982-05-12

Adverse events under product code JDG

product code JDG

Injury: 804
Malfunction: 3,242
Total: 4,046

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.