DeviceClearance

Product code LZN— General, Plastic Surgery

CEMSTOP CEMENT RESTRICTOR

Classification name
Cement Obturator
Device class
Class 2
Regulation
21 CFR 878.3300
Advisory panel
General, Plastic Surgery
Total cleared
37
First cleared
Most recent

Market context for product code LZN

FDA has cleared 37 devices under product code LZN between 1977 and 2022, filed by 28 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 LZN

Recent clearances under product code LZN

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