Device Classification Name |
prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
|
510(k) Number |
K180263 |
Device Name |
EcoFit Vit E Acetabular System |
Applicant |
implantcast Gmbh |
Lueneburger Schanze 26 |
Buxtehude,
DE
21614
|
|
Applicant Contact |
Juliane Hoeppner |
Correspondent |
Musculoskeletal Clinical Regulatory Advisers, LLC |
1050 K Street NW |
Suite 1000 |
Washington,
DC
20001
|
|
Correspondent Contact |
Dave McGurl |
Regulation Number | 888.3353
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/30/2018 |
Decision Date | 07/20/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|