Device Classification Name |
prosthesis, hip, semi-constrained, metal/polymer, cemented
|
510(k) Number |
K960025 |
Device Name |
PROTEK LOW PROFILE ACETABULAR CUP |
Applicant |
INTERMEDICS ORTHOPEDICS |
9900 SPECTRUM DR. |
AUSTIN,
TX
78717
|
|
Applicant Contact |
JACQUELYN HUGHES |
Correspondent |
INTERMEDICS ORTHOPEDICS |
9900 SPECTRUM DR. |
AUSTIN,
TX
78717
|
|
Correspondent Contact |
JACQUELYN HUGHES |
Regulation Number | 888.3350
|
Classification Product Code |
|
Date Received | 01/02/1996 |
Decision Date | 06/07/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|