Device Classification Name |
fastener, fixation, biodegradable, soft tissue
|
510(k) Number |
K123393 |
Device Name |
HEALICOIL SUTURE ANCHOR WITH REGENESORB |
Applicant |
SMITH & NEPHEW, INC. |
150 MINUTEMAN RD. |
ANDOVER,
MA
01810
|
|
Applicant Contact |
SUE DAHLQUIST |
Correspondent |
SMITH & NEPHEW, INC. |
150 MINUTEMAN RD. |
ANDOVER,
MA
01810
|
|
Correspondent Contact |
SUE DAHLQUIST |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 11/02/2012 |
Decision Date | 04/11/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|