Device Classification Name |
fastener, fixation, biodegradable, soft tissue
|
510(k) Number |
K183236 |
Device Name |
Rotium Bioresorbable Wick |
Applicant |
Nanofiber Solutions, LLC |
4389 Weaver Court North |
Hilliard,
OH
43026
|
|
Applicant Contact |
Ronald L. Bracken |
Correspondent |
Nanofiber Solutions, LLC |
4389 Weaver Court North |
Hilliard,
OH
43026
|
|
Correspondent Contact |
Ronald L. Bracken |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 11/20/2018 |
Decision Date | 03/11/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|