Device Classification Name |
plate, fixation, bone
|
510(k) Number |
K133930 |
Device Name |
FLOWER REAR FOOT PLATING SET, FLOWER CALCANEUS PLANTING SET, FLOWER REARFOOT PLATING SET |
Applicant |
FLOWER ORTHOPEDICS CORPORATION |
100 Witmer Rd Ste 280 |
Horsham,
PA
19044
|
|
Applicant Contact |
GARY BARNETT |
Correspondent |
FLOWER ORTHOPEDICS CORPORATION |
100 Witmer Rd Ste 280 |
Horsham,
PA
19044
|
|
Correspondent Contact |
GARY BARNETT |
Regulation Number | 888.3030
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/23/2013 |
Decision Date | 03/27/2014 |
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
|
|
|