Device Classification Name |
Plate, Fixation, Bone
|
510(k) Number |
K132594 |
Device Name |
CROSSCHECK PLATING SYSTEM |
Applicant |
SOLANA SURGICAL, LLC |
6363 POPLAR AVENUE |
SUITE 312 |
MEMPHIS,
TN
38119
|
|
Applicant Contact |
JOE CLIFT |
Correspondent |
SOLANA SURGICAL, LLC |
6363 POPLAR AVENUE |
SUITE 312 |
MEMPHIS,
TN
38119
|
|
Correspondent Contact |
JOE CLIFT |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 08/19/2013 |
Decision Date | 12/13/2013 |
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
|
|
|