Device Classification Name |
Prosthesis, Toe, Constrained, Polymer
|
510(k) Number |
K153609 |
Device Name |
RTS Flexible 1 MPJ Implant w/Grommets |
Applicant |
In2BonesUSA, LLC |
6060 Poplar Ave, Suite 380 |
Mephis,
TN
38119
|
|
Applicant Contact |
Joe Clift |
Correspondent |
ENMED International, Inc |
PO Box 249 |
Del Mar,
CA
92014
|
|
Correspondent Contact |
Louise Focht |
Regulation Number | 888.3720
|
Classification Product Code |
|
Date Received | 12/17/2015 |
Decision Date | 09/08/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|