Device Classification Name |
thoracolumbosacral pedicle screw system
|
510(k) Number |
K193396 |
Device Name |
PERLA® TL posterior osteosynthesis system |
Applicant |
Spineart |
3 chemin du pre Fleuri |
Plan Les Ouates,
CH
1228
|
|
Applicant Contact |
Franck Pennesi |
Correspondent |
Spineart |
3 chemin du pre Fleuri |
Plan Les Ouates,
CH
1228
|
|
Correspondent Contact |
Franck Pennesi |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/06/2019 |
Decision Date | 02/05/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|