Medical Designs, LLC

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
7
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K182352SP-LINK™ SystemNovember 21, 2018
K181591Fixated Asfora BULLET CAGE® (FABC)September 26, 2018
K143688ASFORA ANTERIOR CERVICAL PLATE SYSTEMJuly 1, 2015
K112648ASFORA BULLET CAGEMarch 13, 2012
K090048ASFORA BULLET CAGE SYSTEMAugust 14, 2009
K042359SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA), (SEPS-CAL), (SEPS-CAND),MODELS 11-0401November 17, 2004
K002970SUBDURAL EVACUATING PORT SYSTEM, MODEL 11-9901December 12, 2000