Device Classification Name |
fastener, fixation, nondegradable, soft tissue
|
510(k) Number |
K081511 |
Device Name |
2.0 PK SUTURE ANCHOR T, 2.0 PK SUTURE ANCHOR S |
Applicant |
SMITH & NEPHEW, INC. |
150 MINUTEMAN RD. |
ANDOVER,
MA
01810
|
|
Applicant Contact |
JANICE HASELTON |
Correspondent |
SMITH & NEPHEW, INC. |
150 MINUTEMAN RD. |
ANDOVER,
MA
01810
|
|
Correspondent Contact |
JANICE HASELTON |
Regulation Number | 888.3040
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/29/2008 |
Decision Date | 08/26/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|