Device Classification Name |
fastener, fixation, biodegradable, soft tissue
|
510(k) Number |
K011299 |
Device Name |
SMITH AND NEPHEW 5.00MM ABSORBABLE POLYMER ANCHOR |
Applicant |
SMITH & NEPHEW, INC. |
160 DASCOMB RD. |
ANDOVER,
MA
01810
|
|
Applicant Contact |
TIM CRABTREE |
Correspondent |
SMITH & NEPHEW, INC. |
160 DASCOMB RD. |
ANDOVER,
MA
01810
|
|
Correspondent Contact |
TIM CRABTREE |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 04/30/2001 |
Decision Date | 06/27/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|