Device Classification Name |
Appliance, Fixation, Spinal Interlaminal
|
510(k) Number |
K072866 |
Device Name |
ISSYS LP SPINAL FIXATION SYSTEM |
Applicant |
CUSTOM SPINE, INC. |
1140 PARSIPPANY BLVD. |
SUITE 201 |
PARSIPPANY,
NJ
07054
|
|
Applicant Contact |
SAAD ATTIYAH |
Correspondent |
CUSTOM SPINE, INC. |
1140 PARSIPPANY BLVD. |
SUITE 201 |
PARSIPPANY,
NJ
07054
|
|
Correspondent Contact |
SAAD ATTIYAH |
Regulation Number | 888.3050
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/05/2007 |
Decision Date | 12/13/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|