Device Classification Name |
Fastener, Fixation, Biodegradable, Soft Tissue
|
510(k) Number |
K151105 |
Device Name |
Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew Suture Anchors - TAG Bioraptor Suture Anchor 7209317, 7209318, Smith and Nephew Suture Anchors - Bioraptor 2.3 PK Suture Anchor, Smith and Nephew Suture Anchors - Osteoraptor Suture Anchor, Smith and Nephew Suture Anchors - Twinfix Ultra HA Suture Anchor, Smith and Nephew Suture Anchors - OSTEORAPTOR Curved Suture Anchors, Smith and Nephew Suture Anchors - Ultra Fast-Fix Meniscal Repair System, Ultra Fa |
Applicant |
Smith & Nephew, Inc. |
130 Forbes Boulevard |
Mansfield,
MA
02048
|
|
Applicant Contact |
Katherine Marcaccio |
Correspondent |
Smith & Nephew, Inc. |
150 Minuteman Road |
Andover,
MA
01810
|
|
Correspondent Contact |
Katherine Marcaccio |
Regulation Number | 888.3030
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/24/2015 |
Decision Date | 07/28/2015 |
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
|
|
|