| 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 |
|