Device Classification Name |
Fastener, Fixation, Biodegradable, Soft Tissue
|
510(k) Number |
K122635 |
Device Name |
TORNIER INSITE FT BIOCOMPOSITE SUTURE ANCHOR |
Applicant |
TORNIER, INC. |
10801 NESBITT AVENUE |
BLOOMINGTON,
MN
55437
|
|
Applicant Contact |
LAEL J PICKETT |
Correspondent |
TORNIER, INC. |
10801 NESBITT AVENUE |
BLOOMINGTON,
MN
55437
|
|
Correspondent Contact |
LAEL J PICKETT |
Regulation Number | 888.3030
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/29/2012 |
Decision Date | 05/13/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|