Device Classification Name |
system, facet screw spinal device
|
510(k) Number |
K192281 |
Device Name |
AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine System, BOWTI Anterior Buttress Staple Spinal System, DISCOVERY Screw System, EXPEDIUM Anterior Spine System, FRONTIER Anterior Scoliosis System, KANEDA Anterior Scoliosis System, KANEDA SR Anterior Spinal Syste |
Applicant |
Medos International SARL |
Chemin-Blanc 38 |
Le Locle,
CH
2400
|
|
Applicant Contact |
Sergio M. Cordeiro |
Correspondent |
DePuy Synthes Spine |
325 Paramount Drive |
Raynham,
MA
02767
|
|
Correspondent Contact |
Sergio M. Cordeiro |
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/22/2019 |
Decision Date | 11/20/2019 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|