DeviceClearance

Product code KWH— Orthopedic

ASCENT KNEE SYSTEM

Classification name
Prosthesis, Toe, Constrained, Polymer
Device class
Class 2
Regulation
21 CFR 888.3720
Advisory panel
Orthopedic
Total cleared
21
First cleared
Most recent

Market context for product code KWH

FDA has cleared 21 devices under product code KWH between 1978 and 2020, filed by 14 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 KWH

Recent clearances under product code KWH

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