Device Classification Name |
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
|
510(k) Number |
K122500 |
Device Name |
NEO PS KNEE SYSTEM |
Applicant |
PIPELINE ORTHOPEDICS |
901 KING STREET, SUITE 200 |
ALEXANDRIA,
VA
22314
|
|
Applicant Contact |
TERRY POWELL |
Correspondent |
PIPELINE ORTHOPEDICS |
901 KING STREET, SUITE 200 |
ALEXANDRIA,
VA
22314
|
|
Correspondent Contact |
TERRY POWELL |
Regulation Number | 888.3560
|
Classification Product Code |
|
Date Received | 08/16/2012 |
Decision Date | 05/03/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|