Device Classification Name |
Bone Wedge
|
510(k) Number |
K191047 |
Device Name |
ADI TiDAL Osteotomy Wedge |
Applicant |
Additive Device, Inc. (ADI) d/b/a restor3d |
311 W Corporation St. |
Durham,
NC
27701
|
|
Applicant Contact |
Nathan Evans |
Correspondent |
Additive Device, Inc. (ADI) d/b/a restor3d |
311 W Corporation St. |
Durham,
NC
27701
|
|
Correspondent Contact |
Nathan Evans |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 04/19/2019 |
Decision Date | 11/05/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|