Device Classification Name |
appliance, fixation, nail/blade/plate combination, multiple component
|
510(k) Number |
K191241 |
Device Name |
AutoStrut |
Applicant |
OrthoSpin |
17 Hatechelet Street |
Misgav,
IL
2017400
|
|
Applicant Contact |
Oren Cohen |
Correspondent |
Hogan Lovells US LPP |
1735 Market Street |
Suite 2300 |
Philadelphia,
PA
19103
|
|
Correspondent Contact |
Janice M. Hogan |
Regulation Number | 888.3030
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/08/2019 |
Decision Date | 08/14/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|