Device Classification Name |
Plate, Fixation, Bone, Non-Spinal, Metallic
More FDA Info for this Device |
510(K) Number |
K021749 |
Device Name |
Plate, Fixation, Bone, Non-Spinal, Metallic |
Applicant |
EBI, L.P.
399 JEFFERSON ROAD
PARSIPPANY, NJ 07054 US
Other 510(k) Applications for this Company
|
Contact |
JON CAPARETTA
Other 510(k) Applications for this Contact |
Regulation Number |
888.3030
More FDA Info for this Regulation Number |
Classification Product Code |
NDF
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
05/28/2002 |
Decision Date |
08/12/2002 |
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 |
|