Device Classification Name |
pin, fixation, smooth
|
510(k) Number |
K211789 |
Device Name |
restor3d Pin Implants |
Applicant |
restor3d |
311 W. Corporation St. |
Durham,
NC
27701
|
|
Applicant Contact |
Lexi Lewis |
Correspondent |
restor3d |
311 W. Corporation St. |
Durham,
NC
27701
|
|
Correspondent Contact |
Lexi Lewis |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 06/10/2021 |
Decision Date | 01/04/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|