Device Classification Name |
prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
|
510(k) Number |
K181061 |
Device Name |
Corin Optimized Positioning System (OPS) Femoral |
Applicant |
Corin USA |
12750 Citrus Park Lane, Suite 120 |
Tampa,
FL
33625
|
|
Applicant Contact |
Lucinda Gerber |
Correspondent |
Corin (Australia) |
17 Bridge Street |
Sydney,
AU
2073
|
|
Correspondent Contact |
Crissy Tomarelli |
Regulation Number | 888.3353
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/23/2018 |
Decision Date | 09/07/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|