DeviceClearance

Product code KTW— Orthopedic

AOS Anterolateral Proximal Humeral Plate

Classification name
Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
Device class
Class 2
Regulation
21 CFR 888.3030
Advisory panel
Orthopedic
Total cleared
38
First cleared
Most recent

Market context for product code KTW

FDA has cleared 38 devices under product code KTW between 1978 and 2019, filed by 25 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code KTW

Adverse events under product code KTW

product code KTW
Injury
220
Total
220

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code KTW

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