Device Classification Name |
Fastener, Fixation, Nondegradable, Soft Tissue
More FDA Info for this Device |
510(K) Number |
K213110 |
Device Name |
Fastener, Fixation, Nondegradable, Soft Tissue |
Applicant |
Auxein Medical Private Limited
Plot No. 168, 169, 170 Phase-IV, Sector 57, Kundli
Industrial area
Sonipat 131028 IN
Other 510(k) Applications for this Company
|
Contact |
Rahul Luthra
Other 510(k) Applications for this Contact |
Regulation Number |
888.3040
More FDA Info for this Regulation Number |
Classification Product Code |
MBI
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
09/24/2021 |
Decision Date |
12/16/2022 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
OR - Orthopedic |
Review Advisory Committee |
OR - Orthopedic |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|