HOFFMANN II COMPACT EXTERNAL FIXATION SYSTEM— 510(k) K971755

Name: FDA 510(k) clearance K971755
Creator: U.S. Food and Drug Administration
Published: 1997-07-17

Substantially Equivalent

Howmedica Corp.

FDA 510(k) clearance K971755 for HOFFMANN II COMPACT EXTERNAL FIXATION SYSTEM, Substantially Equivalent on 1997-07-17. Applicant: Howmedica Corp.. Device class: 2.

Clearance details

Applicant: Howmedica Corp.
Product code: Code JEC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 1997-05-12
Decision date: 1997-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rutherford, NJ, 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 Howmedica Corp.

view all

K983528 — MICRO DYNAMIC MESH1998-12-23
K983404 — TYPE 3 FEMORAL COMPONENTS1998-12-22
K980925 — DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION1998-12-16
K980926 — DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION1998-12-16
K980626 — DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION1998-12-11

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