Device Classification Name |
Orthosis, Spinal Pedicle Fixation
|
510(k) Number |
K150049 |
Device Name |
PASS LP Spinal System |
Applicant |
MEDICREA INTERNATIONAL |
14 PORTE DU GRAND LYON |
NEYRON,
FR
01700
|
|
Applicant Contact |
Audrey Vion |
Correspondent |
MEDICREA INTERNATIONAL |
14 PORTE DU GRAND LYON |
NEYRON,
FR
01700
|
|
Correspondent Contact |
Audrey Vion |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 01/12/2015 |
Decision Date | 02/10/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|