Device Classification Name |
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
|
510(k) Number |
K122158 |
FOIA Releasable 510(k) |
K122158
|
Device Name |
PBP TOTAL HIP SYSTEM |
Applicant |
PIPELINE BIOMEDICAL PRODUCTS, LLC |
901 KING STREET |
SUITE 200 |
ALEXANDRIA,
VA
22314
|
|
Applicant Contact |
TERRY POWELL |
Correspondent |
PIPELINE BIOMEDICAL PRODUCTS, LLC |
901 KING STREET |
SUITE 200 |
ALEXANDRIA,
VA
22314
|
|
Correspondent Contact |
TERRY POWELL |
Regulation Number | 888.3358
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/20/2012 |
Decision Date | 12/11/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|