Device Classification Name |
appliance, fixation, spinal intervertebral body
|
510(k) Number |
K103838 |
Device Name |
FIXED VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM |
Applicant |
PRECISION SURGERY LTD. |
8202 SHERMAN ROAD |
CHESTERLAND,
OH
44026 -2141
|
|
Applicant Contact |
KAREN E WARDEN, PHD. |
Correspondent |
PRECISION SURGERY LTD. |
8202 SHERMAN ROAD |
CHESTERLAND,
OH
44026 -2141
|
|
Correspondent Contact |
KAREN E WARDEN, PHD. |
Regulation Number | 888.3060
|
Classification Product Code |
|
Date Received | 12/30/2010 |
Decision Date | 02/15/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|