CEMENT RESTRICTOR— 510(k) K840413

Substantially Equivalent

American Ortomed Corp.

FDA 510(k) clearance K840413 for CEMENT RESTRICTOR, Substantially Equivalent on 1984-03-05. Applicant: American Ortomed Corp.. Device class: 2.

Clearance details

Applicant: American Ortomed Corp.
Product code: Code JDK
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 1984-01-31
Decision date: 1984-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JDK

K210062 — Mectaplug PE II2021-04-08
K061465 — KMI CEMENT RESTRICTOR IMPLANT2006-10-05
K061698 — MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR2006-07-12
K060247 — LIFE SPINE CEMENT RESTRICTOR2006-05-11
K060132 — SPINAL USA CEMENT RESTRICTOR SYSTEM2006-03-16

More clearances from American Ortomed Corp.

K842466 — TITANIUM MITTELMEIER TYPE ACETABULAR1985-01-30
K842518 — UNILOC-CEMENTLESS & SELF TAP ACETABULAR1985-01-30
K842465 — UNILOC1984-11-19
K820719 — THE ICR KNEE1982-05-12
K780497 — SPHERISTEM TOTAL HIP PROSTHESIS1978-06-14

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