Device Classification Name |
arthroscope
|
510(k) Number |
K121548 |
Device Name |
SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS) |
Applicant |
SPINE VIEW, INC. |
48810 Kato Rd. Suite 100E |
Fremont,
CA
94538
|
|
Applicant Contact |
Diana DeGregorio |
Correspondent |
SPINE VIEW, INC. |
48810 Kato Rd. Suite 100E |
Fremont,
CA
94538
|
|
Correspondent Contact |
Diana DeGregorio |
Regulation Number | 888.1100
|
Classification Product Code |
|
Date Received | 05/25/2012 |
Decision Date | 08/16/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|