Device Classification Name |
fastener, fixation, nondegradable, soft tissue
|
510(k) Number |
K100159 |
Device Name |
SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHOR |
Applicant |
SMITH & NEPHEW INC., ENDOSCOPY DIV. |
150 MINUTEMAN RD. |
ANDOVER,
MA
01810
|
|
Applicant Contact |
CHRISTINA FLORES |
Correspondent |
SMITH & NEPHEW INC., ENDOSCOPY DIV. |
150 MINUTEMAN RD. |
ANDOVER,
MA
01810
|
|
Correspondent Contact |
CHRISTINA FLORES |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 01/20/2010 |
Decision Date | 04/19/2010 |
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
|
|
|