Device Classification Name |
prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
|
510(k) Number |
K203420 |
Device Name |
EcoFit® Hip System |
Applicant |
Implantcast, GmbH |
Luneburger Schanze 26 |
21614 Buxtehude,
DE
|
|
Applicant Contact |
Juliane Hoppner |
Correspondent |
MCRA, LLC. |
1050 K Street NW, Suite 1000 |
Washington,
DC
20001
|
|
Correspondent Contact |
Dave McGurl |
Regulation Number | 888.3353
|
Classification Product Code |
|
Date Received | 11/19/2020 |
Decision Date | 02/03/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|