MALLEOLAR SCREW— 510(k) K931686

Name: FDA 510(k) clearance K931686
Creator: U.S. Food and Drug Administration
Published: 1994-04-05

Substantially Equivalent

Onyx Medical Corp.

FDA 510(k) clearance K931686 for MALLEOLAR SCREW, Substantially Equivalent on 1994-04-05. Applicant: Onyx Medical Corp.. Device class: 2.

Clearance details

Applicant: Onyx Medical Corp.
Product code: Code KTW
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 1993-04-05
Decision date: 1994-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KTW

view all

K182285 — PK High Tibial Osteotomy Correction System2019-06-20
K171606 — AOS Anterolateral Proximal Humeral Plate2017-06-22
K170693 — Phantom Small Bone Intramedullary Nail System2017-06-19
K160409 — AOS Anterolateral Proximal Humeral Plate2016-03-15
K122541 — ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP)2012-09-20

More clearances from Onyx Medical Corp.

view all

K942022 — FACE-IT SHIELD1994-07-08
K931690 — SPOON PLATE1994-06-07
K931680 — CANNULATED CANCELLOUS SCREW1994-05-04
K931684 — EPIPHYSIS PLATE1994-05-04
K931692 — T-PLATE1994-05-04

Adverse events under product code KTW

product code KTW

Injury: 220
Total: 220

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.