DeviceClearance

Product code KKY— General, Plastic Surgery

STRYKER PATIENT SPECIFIC POLYMER IMPLANT

Classification name
Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Device class
Class 2
Regulation
21 CFR 878.3500
Advisory panel
General, Plastic Surgery
Total cleared
25
First cleared
Most recent

Market context for product code KKY

FDA has cleared 25 devices under product code KKY between 1978 and 2021, filed by 22 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 KKY

Recent clearances under product code KKY

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