Device Classification Name |
Spinal Vertebral Body Replacement Device
|
510(k) Number |
K173787 |
Device Name |
X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh System, BENGAL Stackable Cage System, BENGAL System, CONCORDE® System, CONCORDE® Inline Lumbar Interbody System, CONCORDE® Curve Lumbar Interbody System, CONCORDE® Bullet Lumbar Interbody System, COUGAR® System, COUGAR® LS Lateral Cage System, DEVEX® System, LEOPARD® System, DePuy PULSE Cervical Cage System, DePuy PULSE Lumbar Cage System, LUMBAR I/F CAGE® System |
Applicant |
Medos International SARL |
Chemin-Blanc 38 |
Le Locle,
CH
2400
|
|
Applicant Contact |
Sheree Geller |
Correspondent |
DePuy Synthes Spine |
325 Paramount Drive |
Raynham,
MA
02767
|
|
Correspondent Contact |
Sheree Geller |
Regulation Number | 888.3060
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/14/2017 |
Decision Date | 06/11/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|