Device Classification Name |
Orthosis, Spinal Pedicle Fixation
|
510(k) Number |
K061978 |
Device Name |
EBI, L.P.'S LINE EXTENSION TO THE ARRAY SPINAL SYSTEM |
Applicant |
EBI, L.P. |
399 JEFFERSON ROAD |
PARSIPPANY,
NJ
07054
|
|
Applicant Contact |
DEBRA BING |
Correspondent |
EBI, L.P. |
399 JEFFERSON ROAD |
PARSIPPANY,
NJ
07054
|
|
Correspondent Contact |
DEBRA BING |
Regulation Number | 888.3070
|
Classification Product Code |
|
Date Received | 07/13/2006 |
Decision Date | 08/11/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|