Device Classification Name |
fastener, fixation, nondegradable, soft tissue
|
510(k) Number |
K093943 |
Device Name |
BIOSURE SYNC TIBIAL FIXATION DEVICE, 6MM, 8MM,10MM,12MM |
Applicant |
SMITH & NEPHEW INC., ENDOSCOPY DIV. |
150 MINUTEMAN RD. |
ANDOVER,
MA
01810
|
|
Applicant Contact |
JULIE ACKER |
Correspondent |
SMITH & NEPHEW INC., ENDOSCOPY DIV. |
150 MINUTEMAN RD. |
ANDOVER,
MA
01810
|
|
Correspondent Contact |
JULIE ACKER |
Regulation Number | 888.3040
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/22/2009 |
Decision Date | 03/05/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|