Device Classification Name |
suture, nonabsorbable, synthetic, polyethylene
|
510(k) Number |
K143356 |
Device Name |
NovoStitch Plus Meniscal Repair System |
Applicant |
Ceterix Orthopaedics, Inc. |
959 Hamilton Ave |
Menlo Park,
CA
94025
|
|
Applicant Contact |
Michael Hendricksen |
Correspondent |
Ceterix Orthopaedics, Inc. |
959 Hamilton Ave |
Menlo Park,
CA
94025
|
|
Correspondent Contact |
Michael Hendricksen |
Regulation Number | 878.5000
|
Classification Product Code |
|
Date Received | 11/24/2014 |
Decision Date | 07/21/2015 |
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 |
No
|
|
|