Device Classification Name |
suture, surgical, absorbable, polydioxanone
|
510(k) Number |
K182873 |
Device Name |
STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices |
Applicant |
Ethicon, Inc. |
Route 22 West, P.O. Box 151 |
Somerville,
NJ
08876
|
|
Applicant Contact |
Ariell Joiner |
Correspondent |
Ethicon, Inc. |
Route 22 West, P.O. Box 151 |
Somerville,
NJ
08876
|
|
Correspondent Contact |
Ariell Joiner |
Regulation Number | 878.4840
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/12/2018 |
Decision Date | 01/10/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
Recalls |
CDRH Recalls
|
|
|