DeviceClearance

Product code KYJ— Orthopedic

ASCENSION SILICONE PIP

Classification name
Prosthesis, Finger, Constrained, Polymer
Device class
Class 2
Regulation
21 CFR 888.3230
Advisory panel
Orthopedic
Total cleared
14
First cleared
Most recent

Market context for product code KYJ

FDA has cleared 14 devices under product code KYJ between 1978 and 2023, filed by 11 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

Top applicants under product code KYJ

Adverse events under product code KYJ

product code KYJ
Injury
210
Total
210

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 KYJ

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