Device Classification Name |
suture, nonabsorbable, synthetic, polyethylene
|
510(k) Number |
K160854 |
Device Name |
MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture |
Applicant |
Biomet Manafacturing Corp. |
56 East Bell Drive |
PO Box 587 |
Warsaw,
IN
46581
|
|
Applicant Contact |
Adam Cargill |
Correspondent |
Biomet Manafacturing Corp. |
56 East Bell Drive |
PO Box 587 |
Warsaw,
IN
46581
|
|
Correspondent Contact |
Jared Cooper |
Regulation Number | 878.5000
|
Classification Product Code |
|
Date Received | 03/28/2016 |
Decision Date | 12/19/2016 |
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
|