Device Classification Name |
fastener, fixation, nondegradable, soft tissue
|
510(k) Number |
K093935 |
Device Name |
SMITH & NEPHEW FOOTPRINT RCX PK SUTURE ANCHOR |
Applicant |
SMITH & NEPHEW, INC. |
150 MINUTEMAN RD. |
ANDOVER,
MA
01810
|
|
Applicant Contact |
CHRISTINA FLORES |
Correspondent |
SMITH & NEPHEW, INC. |
150 MINUTEMAN RD. |
ANDOVER,
MA
01810
|
|
Correspondent Contact |
CHRISTINA FLORES |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 12/22/2009 |
Decision Date | 04/05/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|