Device Classification Name |
prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
|
510(k) Number |
K150133 |
Device Name |
PROFEMUR Preserve Size 1-3 Hip Stems |
Applicant |
MICROPORT ORTHOPEDICS, INC. |
5677 AIRLINE ROAD |
ARLINGTON,
TN
38002
|
|
Applicant Contact |
BYRON LEDBETTER |
Correspondent |
MICROPORT ORTHOPEDICS, INC. |
5677 AIRLINE ROAD |
ARLINGTON,
TN
38002
|
|
Correspondent Contact |
BYRON LEDBETTER |
Regulation Number | 888.3353
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 01/21/2015 |
Decision Date | 04/20/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|