Device Classification Name |
orthosis, spinal pedicle fixation
|
510(k) Number |
K031354 |
Device Name |
EBI OMEGA21 SPINAL FIXATION SYSTEM |
Applicant |
EBI, L.P. |
399 JEFFERSON ROAD |
PARSIPPANY,
NJ
07054
|
|
Applicant Contact |
FREDERIC TESTA |
Correspondent |
EBI, L.P. |
399 JEFFERSON ROAD |
PARSIPPANY,
NJ
07054
|
|
Correspondent Contact |
FREDERIC TESTA |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/29/2003 |
Decision Date | 08/06/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|