RICHARDS FIXATOR SYSTEM— 510(k) K841334

Name: FDA 510(k) clearance K841334
Creator: U.S. Food and Drug Administration
Published: 1984-05-16

Substantially Equivalent

Richards Medical Co., Inc.

FDA 510(k) clearance K841334 for RICHARDS FIXATOR SYSTEM, Substantially Equivalent on 1984-05-16. Applicant: Richards Medical Co., Inc.. Device class: 2.

Clearance details

Applicant: Richards Medical Co., Inc.
Product code: Code JEC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 1984-04-02
Decision date: 1984-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JEC

view all

K203605 — SteriTrak2021-04-23
K193256 — Anjon Bremer Halo System2020-03-02
K192465 — DigiFix Sterile Kit2019-10-10
K181192 — PIP Fix2018-10-22
K171863 — Anjon Bremer Halo System2018-03-19

More clearances from Richards Medical Co., Inc.

view all

K896106 — ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTS1990-06-25
K900628 — MODULAR HIP SYSTEM1990-05-09
K896580 — UNI-POLAR HEAD1990-02-15
K895241 — INTRAMEDULLARY HIP SCREW1990-01-04
K884824 — TRICON-M TOTAL KNEE SYSTEM1989-11-21

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