CENTRAFIX EXTERNAL FIXATOR— 510(k) K991732

Name: FDA 510(k) clearance K991732
Creator: U.S. Food and Drug Administration
Published: 1999-05-21

Substantially Equivalent

Owandar Medical, Ltd.

FDA 510(k) clearance K991732 for CENTRAFIX EXTERNAL FIXATOR, Substantially Equivalent on 1999-05-21. Applicant: Owandar Medical, Ltd.. Device class: 2.

Clearance details

Applicant: Owandar Medical, Ltd.
Product code: Code JEC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 1999-05-21
Decision date: 1999-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hp14 3xp, GB

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

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