Device Classification Name |
appliance, fixation, spinal interlaminal
|
510(k) Number |
K121136 |
Device Name |
RENOIR POSTERIOR CERVIAL FIXATION SYSTEM |
Applicant |
ACCEL SPINE |
14850 Quorum Dr Ste 220 |
Dallas,
TX
75254
|
|
Applicant Contact |
DANIEL CHON |
Correspondent |
ACCEL SPINE |
14850 Quorum Dr Ste 220 |
Dallas,
TX
75254
|
|
Correspondent Contact |
DANIEL CHON |
Regulation Number | 888.3050
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/13/2012 |
Decision Date | 08/09/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|